Invasix InMode Operator's Manual

810/1064 / Lumecca™ / Fractora™ / Forma™ / Plus™ / BodyFX™ / MiniFX™ DO606736C Copyright © Invasix Ltd. Date: June 2018 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Invasix Ltd. 🏭 Invasix Ltd Tavor House, POB 533, Industrial Park South, Yokneam, 2069206, Israel For information call: +972-4-9096313 I InMode Spain Pati de la Abadia nº1, Breda 17400 Girona, Spain Contact person: Jorge Alorda Guibernau Tel.:+34-670 486 026 E-mail: [email protected]

1 ..............................................................................................Section 1: Introduction 1.1 Before You Start 1 ..................................................................................................... 1.2 1 ................................................................................................... System Overview 1.3 Conventions Used in the Manual 1 ........................................................................... 1.4 Explanation of the Symbols used on the System 2 ................................................... 3 ........................................................................................................ Section 2: Safety 2.1 The Patient 3 ............................................................................................................. 2.2 3 ................................................................................................ Treating Attendant 2.3 4 ................................................................................................................. Cautions 2.4 4 ....................................................................................................... Ocular Hazards 2.5 Ocular Safety Considerations 5 ................................................................................. 2.6 5 ........................................................................... Electrical and Mechanical Safety 2.7 6 ........................................................................................................... Fire Hazards 2.8 6 ............................................................................... Safety Features of the System 2.9 8 ........................................................................ Safe Use of the Active Accessories 2.10 8 ................................................................................................................ Warnings 2.11 11 ....................................................................................................... Device Labels 2.12 12 . ................................................................................................ Handpiece Labels 2.13 14 ......................................................................................Equipment Classification Section 3: System Installation 16 ................................................................................. 3.1 16 ....................................................................................... Electrical Requirements 3.2 16 .............................................................................. Environmental Requirements 3.3 16 ..................................................................................................... Equipment List 3.4 11 ............................................................................................................ Unpacking 3.5 18 ........................................................................................................... Installation 3.6 18 ......................................................................................................... Filling Water 3.7 18 .............................................................................................. Moving the System 3.8 11 ................................................................................................... System Disposal 21 ................................................................................. Section 4: Device Description 4.1 21 ............................................................................................................ Rear Panel 4.2 21 ............................................................. Front Panel and Operator Control Panel 4.3 22 . ................................................................................................ Software Screens 4.4 Sound Indicator 31 .................................................................................................... 4.5 31 .............................................................................. Cut-Off Temperature Control 4.6 31 ...........................................................................................................Handpieces 36 .................................................................................. Section 5: System Operation 5.1 36 .................................................................................................... Device Start-Up 5.2 31 ................................................................................................ System Shutdown

6.1 38 ............................................................................................... Indications for Use 6.2 Contraindications 38 . ................................................................................................ 6.3 31 ...................................................................................... Possible Adverse Effects 6.4 31 ....................................................................... Pre-treatment Recommendations 6.5 41 . ................................................................ Tip Cleaning Instructions Prior to Use 6.6 41 ............................................................................. Treatment Recommendations 6.7 Treatment Schedule 42 ............................................................................................. 6.8 42 ..................................................................... Post Treatment Recommendations 43 ......................................................... Section 7: DiolazeXL Treatment Information 7.1 43 ............................................................................................... Indications for Use 7.2 Contraindications 43 . ................................................................................................ 7.3 44 ...................................................................................... Possible Adverse Effects 7.4 45 ...................................................................... Pre-Treatment Recommendations 7.5 45 . ................................................................ Tip Cleaning Instructions Prior to Use 7.6 45 ............................................................................. Treatment Recommendations 7.7 Treatment Schedule 41 ............................................................................................. 7.8 Post-Treatment Recommendations 41 ..................................................................... Section 8: Lumecca Treatment Information 48 ........................................................... 8.1 48 ..............................................................................................Instructions for Use 8.2 Contraindications 48 . ................................................................................................ 8.3 41 ...................................................................................... Possible Adverse Effects 8.4 41 ..................................................................................................... Pre-Treatment 8.5 51 . ................................................................ Tip Cleaning Instructions Prior to Use 8.6 51 ............................................................................. Treatment Recommendations 8.7 Post-Treatment Recommendations 51 ..................................................................... 8.8 Treatment Schedule 52 ............................................................................................. 53 ........................................................... Section 9: Fractora Treatment Information 9.1 53 .................................................................................. Fractional Skin Resurfacing 9.2 53 ..............................................................................................Instructions for Use 9.3 Contraindications 53 . ................................................................................................ 9.4 55 ...................................................................................... Possible Adverse Effects 9.5 55 ...................................................................... Pre-Treatment Recommendations 9.6 56 . ................................................................ Tip Cleaning Instructions Prior to Use 9.7 Test Spots 56 ............................................................................................................. 9.8 51 ............................................................................. Treatment Recommendations 9.9 Treatment Schedule 51 ............................................................................................. 9.10 Post-Treatment Recommendations 51 .....................................................................

10.1 61 ..............................................................................................Instructions for Use 10.2 Contraindications 61 . ................................................................................................ 10.3 62 ...................................................................................... Possible Adverse Effects 10.4 62 ..................................................... Handpiece Cleaning Instructions Prior to Use 10.5 63 ...................................................................... Pre-Treatment Recommendations 10.6 64 ............................................................................. Treatment Recommendations 10.7 Treatment Schedule 66 ............................................................................................. 10.8 Post-Treatment Recommendations 66 ..................................................................... 68 ............................................. Section 11: BodyFX/MiniFX Treatment Information 11.1 68 ............................................................................................... Indications for Use 11.2 Contraindications 68 . ................................................................................................ 11.3 61 ...................................................................................... Possible Adverse Effects 11.4 61 ..................................................... Handpiece Cleaning Instructions Prior to Use 11.5 11 ...................................................................... Pre-Treatment Recommendations 11.6 11 ............................................................................. Treatment Recommendations 11.7 Treatment Schedule 13 ............................................................................................. 11.8 Post-Treatment Recommendations 13 ..................................................................... 14 ........................................................................... Section 12: System Maintenance 12.1 14 .................................................................................. Maintenance & Frequency 12.2 Before and after each treatment 14 ......................................................................... 12.3 14 ........................................................................................................ Once a Week 12.4 14 ...................................................................................................... Once a Month 12.5 14 .......................................................................................................... Once a Year 12.6 15 ............................................... Filling Water for Diolaze, DiolazeXL and Lumecca 12.7 Draining Water for Diolaze, DiolazeXL and Lumecca 11 ........................................... 12.8 18 ...................... Draining the Laser/IPL Handpieces with the Water Draining Tool 12.9 11 ....................................................................... Replacing the Deionizer Cartridge 12.10 81 .................................................................................Replacing the Capsule Filter 12.11 81 ............................................................................................................... Air Filter 83 .................................................................................... Section13: Troubleshooting 13.1 83 ........................................................... Description of Faults with All Handpieces 85 .......................................................................... Section 14: System Specifications 14.1 Output Power Curves 81 ........................................................................................... 14.2 11 ........................................................................................................... EMC Safety 15 ............................................................... Table from IEC60601-1-2, / 5.2.2.1 C & F

Section 1: Introduction 1 of 96 Section 1: Introduction 1.1 Before You Start The manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique to be performed. Federal (USA) law restricts sale of this device by or on the order of a physician. Read this manual to become familiar with all safety requirements and operating procedures before attempting to operate the System. 1.1 System Overview The InMode™ System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Diolaze™, DiolazeXL™ laser hand pieces for hair removal, Lumecca™ IPL for skin rejuvenation, Fractora™ radiofrequency (RF) for fractional resurfacing, Forma™/Plus™ RF for facial and body wrinkle treatment and BodyFX™/MiniFX™ RF for body contouring, fat and cellulite treatment. The System provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient. The System provides enhanced safety while minimizing possible side effects by monitoring RF parameters. 1.1 Conventions Used in the Manual The following conventions in the form of notes and warnings are used in this manual: WARNING! This information is extremely important! ATTENTION! Consult Accompanying Document.  Provides general information that is important to keep in mind.

Section 1: Introduction 2 of 96 1.1 Explanation of the Symbols used on the System Symbol Description CSA marking (212603 CSA master contract number) Do not discard in trash. Electronic equipment should be disposed of in an appropriate manner Fuse Type B Equipment. Type BF Equipment HF Isolated Patient Circuit This equipment intentionally supplies non-ionizing RF energy Follow the operating instructions Do not reuse/single use only. This symbol is used for disposable one-time-use products. CE Marking -1: Device Symbols1Figure

Section 2: Safety 3 of 96 Section 2: Safety This chapter describes safety issues regarding the use and maintenance of the Diolaze and DiolazeXL laser Handpieces, Lumecca™ IPL InMode™ System with the Handpieces, Fractora™, Forma™/Plus™ and BodyFX™/MiniFX™ RF Handpieces, with a special emphasis on electrical, optical, and laser safety, as applicable. The System is designed for safe and reliable treatment when used in accordance with proper operation and maintenance procedures. Only trained, qualified practitioners can use the System. The operator and all other personnel operating or maintaining the System should be familiar with the safety information provided in this Section. The primary consideration should be to maximize safety for both treating attendant and patient. Read this chapter to be familiar with all its safety requirements and operating procedures prior to system operation. The laser, IPL or RF energy can cause injury if used improperly. High voltage is present inside the System. Always be aware of the possible dangers and take proper safeguards as described in the manual. 1.1 The Patient Well-trained staff is key for assuring patient safety. A patient history report should be completed prior to scheduling. Patients should be fully informed of the treatment details, the likely results and any risks associated with the treatment. Jewelry and metal accessories that are within the activation range of the Handpiece should be removed to avoid accidental laser/light reflection or RF conduction, as applicable. Protective eyewear must be used by patient during Diolaze and DiolazeXL lasers or Lumecca IPL treatments. 1.1 Treating Attendant Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the InMode System.

Section 2: Safety 4 of 96 Personnel should not operate the System until they have been fully educated in its use. Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly. There are no user-serviceable parts in the System, and all service and repair must be performed only by the factory or authorized field service technicians. Protective goggles must be used by all treatment attendants when using the Diolaze and DiolazeXL lasers or the Lumecca IPL. 1.1 Cautions The following cautions should be heeded for safe System use: Do not touch the System’s inner parts.  Service is supplied by company authorized personal only.   To avoid damage, do not allow the Handpiece to come in contact with hard materials. 1.1 Ocular Hazards The light emitted by the Diolaze and DiolazeXL Handpieces are capable of causing serious eye damage or blindness. The light emitted by the Lumecca IPL Handpiece is capable of causing eye irritation or damage. All persons potentially subject to exposure must wear protective goggles or eyewear whenever the main power is on, in accordance with national and international standards. The protective eyewear must have an optical density (OD) of 5 or greater at the Diolaze and DiolazeXL lasers wavelength of 730 - 1085nm (OD 5); 755nm (OD 7); 1064nm(OD >6); at the Lumecca IPL wavelength of 515-1200 nm. For users outside the U.S., the protection values are for 730-1085, DIR LB5; for 755, DIR LB6 + IR LB7; and for 1064, DIR LB6 + IR LB7. All approved by PSP S CE. The laser and the IPL are to be operated only in an enclosed room with protective eyewear for all persons; direct eye exposure is not safe at any distance within the room. All windows in the laser room must be covered with opaque material, and measures should be taken to prevent unauthorized access to the room. For the laser, a remote Interlock is provided, which can be connected to the treatment room doors, disabling laser output if the door is opened during a procedure. In addition, compliance with ANSI Z1 36.3 and EN 60825-l requires that laser safety signs be posted at all entrances whenever the laser is in use. Compliance with IEC 60601-2-57 requires that warning label from IR exposure be posted at all entrances whenever the IPL is in use. Approved sign is provided with each system along with protective eyewear. Additional eyewear or safety signs may be obtained from the manufacturer.

Section 2: Safety 5 of 96 Never look directly into the laser aperture at the distal end of the Handpiece, even if you are wearing safety glasses. Serious eye injury or blindness could result. Avoid directing the laser beam anywhere other than the calibration port or intended treatment area. Stray laser light and reflection is always a potential hazard and may cause serious injury. Do not treat eyebrows, eyelashes, eyelids or other areas within the bony area surrounding the orbit. The light emitted by the laser or the IPL is capable of causing serious eye damage or blindness. For maximum safety, metal eye goggles must be worn by the patient for all facial treatments when laser is used. 1.2 Ocular Safety Considerations  Identify the laser room clearly by posting approved safety signs in prominent locations. Cover all windows to prevent laser light from escaping the laser room.   Restrict entry to the treatment room when the laser or IPL is in use. Allow access to those personnel both essential to the procedure and well trained in safety issues.  Never direct the laser beam at anything other than the calibration port or the intended treatment site. Never look directly into the laser aperture at the distal end of the Handpiece.   All persons in the treatment room must wear approved laser safety eyewear. This includes the operator, patient, nurses, and any other persons in the treatment room.  Do not attempt to remove the plastic shell protective covers on the Handpiece which could allow exposure to high intensity laser light. 1.2 Electrical and Mechanical Safety  Keep all covers and panels of the System closed. Removing the covers creates a safety hazard. Keep hands away from the Applicator during the System start-up.   Perform maintenance procedures when the System is shut down and disconnected from the power.  The System is grounded through the grounding conductor in the power cable. This protective grounding is essential for safe operation.

Section 2: Safety 6 of 96  Move the System slowly and carefully. The System weighs approximately 32kg (70lb.) and may cause injury if proper care is not used when moving it. For RF Handpieces provide as much distance as possible between the system and  other electronic equipment as the activated RF generator may cause interference between them. 1.2 Fire Hazards The absorption of diode laser or IPL energy raises the temperature of the  absorbing material. Do not use the System in the presence of explosive or flammable materials. Materials conducting RF energy causes temperature rise of the absorbing  material. Do not use the System in the presence of explosive or flammable materials conductive to RF.  Keep drapes and towels moist to prevent them from igniting and burning. Use non-flammable prepping solutions.  Do not use flammable substances when preparing the skin for treatment. Be especially careful with the use of oxygen.  If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before the System is used. 1.2 Safety Features of the System The system incorporates the following safety features. All personnel operating the system should be familiar with these features.  The System has a unique password to avoid device operation by non-authorized personnel.  The power electronics cannot be fully activated unless the Applicator and Footswitch have been connected to the System. With IPL, connection of the Applicator is sufficient. An audible tone indicates energy activation.  During activation, the System performs a self-test of the hardware.   The hardware is tested every 10ms to ensure proper operation of electrical circuit. The System starts at a low power setting. 

Section 2: Safety 7 of 96  Temperature monitoring disables the System operation if the Handpiece sapphire temperature is outside the operating range for Diolaze and DiolazeXL and Lumecca Handpieces.  The power electronics cannot be fully activated unless the laser or RF Handpieces and Footswitch have been connected to the System. With IPL Handpieces, the connection of the Applicator is sufficient.  Diolaze and DiolazeXL Handpieces contains a comprehensive monitoring system that allows operation only when numerous safety conditions have been met. A fault must be corrected and the system reset before laser operation is re- enabled. Monitoring includes the following:  Remote Interlock allows laser emission only when there is electrical continuity across the contacts of the remote Interlock Connector (located on the rear of the Console). The System is shipped with a remote Interlock Jumper already connected, providing electrical continuity and allowing the laser to operate. To set up a remote Interlock Switch, such as on the treatment room door, please contact qualified personnel.  The Diolaze and DiolazeXL Hand Triggers allow laser emission only when the Footswitch is pressed.  Laser Energy monitoring to verify that the laser output is within specific energy tolerances for every laser pulse. If abnormally low or high, the laser current (indicative of optical energy) is detected, a System fault is triggered, and the user is notified.  As a safety feature and in compliance with U.S. and international regulations, the Diolaze and DiolazeXL Handpieces contain an Electronic Shutter to help prevent inadvertent laser emissions. The Shutter which is located on the Console, is an electronic switch that is independent of, and in addition to, the normal energy circuit for the laser when it is ON.  Releasing the Diolaze and DiolazeXL Handpiece Trigger will stop laser emissions. In the event of an emergency, the laser can be shut down immediately by pushing the Emergency Stop Button located on the Console. To restore operations, rotate the Button clockwise until it pops out again. Then follow the standard startup sequence. Since the Emergency Stop Button is not intended for routine use, please follow the procedure in the System Operation Section for normal shutdown. For the RF applications: There is skin temperature monitoring for Forma, Plus, and BodyFX/MiniFX.   There is vacuum level monitoring for BodyFX/MiniFX. RF is disabled when the vacuum is below the predetermined level.

Section 2: Safety 8 of 96 1.2 Safe Use of the Active Accessories  Examine the connection of the Handpiece through the Connector to the System before using. Ensure that the accessory functions as intended. Improper connection may result in arcs and sparks, accessory malfunction, or unintended treatment effects.  Do not wrap the Handpiece cords around metal objects. It may induce current that could lead to electrical shocks, fire or injury to the patient or personal.  Don’t direct the laser or IPL towards the window, other treatment attendants or on patient areas that are not intended to be treated.  When using the RF applicators, ensure that all electrodes are in full contact with the skin. Bad coupling of both electrodes (FORMA/PLUS, BodyFX/MiniFX) with the skin results in a specific warning sound, a message on the screen, and disabling of RF. Warnings 1.12 Do not connect a wet accessory to the System. Do not immerse the Applicator under water at any time. This equipment is for use only by trained, licensed physicians. Only Handpieces manufactured or approved by Invasix Ltd. should be used with InMode System. Connect the Power Cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. Connect the System Power Cord to a properly grounded receptacle. Do not use power plug adapters. Always turn off and unplug the device before cleaning. The patient and treatment attendants must use protective eyewear during the use of laser and IPL.

Section 2: Safety 9 of 96 The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Treatment bed or chair should not be electric! Use the lowest output setting necessary to achieve the desired treatment effect. The higher optical or RF energy is applied, the greater the possibility of unintended thermal damage of skin. Failure of the equipment could result in an unintended increase of output power. The cables of the Handpieces should be positioned in such a way that contact with the patient or other leads is avoided. Fire / Explosion Hazard - The following substances will contribute to increased fire and explosion hazards in the operating room: – Flammable substances (such as alcohol-based skin prepping agents and tinctures). – Naturally occurring flammable gases which may accumulate in body cavities such as the bowel. Oxygen enriched atmospheres. – Oxidizing agents (such as nitrous oxide [N2O] atmospheres). – Endogenous gases. – The optical or RF energy and heating associated with the System can provide an ignition source. Observe fire precautions at all times. When using InMode in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where InMode procedures are performed. The operation of the InMode System may adversely influence the operation of other electronic equipment. To avoid the risk of electric shock, this equipment must only be connected to a mains supply with protective earth.

Section 2: Safety 10 of 96 Device Labels 1.11 As required by national and international regulatory agencies, appropriate warning and information labels have been attached to specific locations on the instrument as identified below. The following device labels are located on the InMode device console: -1: System Certification and Identification Label2Figure -2: Laser Emission Warning Label2Figure

Section 2: Safety 11 of 96 -3: Laser Interlock Label2Figure -4: IPL Warning Label2Figure -5: IPL Emission Warning Label2Figure

Section 2: Safety 12 of 96 -6: Emergency Stop Label on the emergency Red Button2Figure -7: Footswitch Label for All Application2Figure Handpiece Labels 1.11 The Handpieces certification and identification labels are attached to connectors on the Handpieces. It states that the product conforms to the performance standards, and indicates the manufacturer’s name, date of manufacturing, model and serial number of the Handpiece.

Section 2: Safety 13 of 96 The following labels are located on the Handpieces: -8: All Handpieces Identification Labels2Figure

Section 2: Safety 14 of 96 -9: DiolazeXL Handpieces Connector Labels2Figure -10: Diolaze and DiolazeXL Handpiece Label for Laser Aperture2Figure -11: 10 Lumecca Handpiece Label for IPL Aperture2Figure Equipment Classification 1.11 The following is a list of the different equipment used and their classifications.  Electric shock protection: Class I, Defibrillation-proof Type B for the optical Handpieces –Diolaze, DiolazeXL and Lumecca, and Type BF for the RF Handpieces Fractora, Forma/Plus, and BodyFX/MiniFX. Protection against ingress of liquids: Ordinary equipment.  Not suitable for use in presence of flammable substance.   Power receptacle must include protective earth and must be checked before connecting the system.

Section 2: Safety 15 of 96 The InMode System with the Diolaze and DiolazeXL Handpieces complies with 21 CFR, Chapter L Subchapter J, as administered by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). CE-labeled devices comply with all appropriate performance standards as specified in Annex II of the Medical Device Directive MDD 93/42/EEC. The InMode System with Diolaze and DiolazeXL Handpieces is classified as a Class IV laser by the CDRH and as a Class 4 laser by the European Standard EN 60825-l. Caution - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. The InMode System with IPL Handpiece is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking. The InMode System with Fractora, Forma, Plus, and BodyFX/MiniFX Handpieces is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking.

Section 3: System Installation 16 of 96 Section 3: System Installation 1.1 Electrical Requirements  The System will require a separate line supply of single phase (100Vac; 15A) or (115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz. Zmax = 0.03Ω. Power receptacles must be within 15 feet of the System site.  The System should not share a power line with other equipment.   Power receptacle must include protective earth, and must be checked before connecting the system. For continued protection against fire, replace the fuse only with one of the same type and rating. Proper grounding is essential for safe operation. 1.1 Environmental Requirements  Corrosive materials can damage electronic parts; therefore, the System should operate in a non-corrosive atmosphere. For optimal operation of the System, maintain room temperature between  20º-27ºC (68º-79ºF) and relative humidity of less than 80%. 1.1 Equipment List The System with all Handpieces includes the following: System platform  Handpieces  Handpiece cradles  Footswitch  Operator manual  Power Cord.  For optical Handpieces:

Section 3: System Installation 17 of 96 User protective goggles.  Patient eyewear.  Laser and IPL “Danger” door signs, as applicable.  1.1 Unpacking In order to unpack the device: .1 Remove the paper strip and open the box .2 Remove accessories and foams around the device. .3 Take the device out of the box using top and bottom handles.

Section 3: System Installation 18 of 96 1.2 Installation The System is designed for installation in a clinic environment. To install the System, perform the following tasks: Check the System and all its components for damage.  Add water. Use the Maintenance screen.  Connect the Cradle to the device (Fig. 3.1).   Connect the Handpiece to the Connector on Front or Rear Panel (Fig 4.1 or 4.2) and place in the Cradle. Connect the Footswitch.  Connect the Power Cord to the System inlet.  Plug the System Power Cord into an appropriate electrical outlet.  -1: Harness Support Assembly3Figure 1.2 Filling Water The InMode System and Diolaze, DiolazeXL and Lumecca Handpieces are shipped without water. Distilled water must be used and failure to do so will void the service warranty. For detailed instructions refer to System Maintenance. 1.2 Moving the System Turn the System off.  Disconnect the Power Cord.  Disconnect and remove the Handpieces.  Disconnect the Footswitch.  Release the Wheel Brakes. 

Section 3: System Installation 19 of 96 Slowly push or pull the System using the Handle.   When moving to another facility, disconnect harness support, lift the System to the vehicle and lay it carefully on its side. For shipment with Diolaze, DiolazeXL and Lumecca, drain the water from the  System and the Handpieces, as described in Section 12- System Maintenance. Never lift, pull or push the System using the operating panel. Always use the handles when moving the System. Upon unpacking, check the System for mechanical damage (e.g., cracks in the Cable insulation). Never leave the system or/and handpieces with water in, exposed to freezing temperatures (< 4°C). 1.2 System Disposal To comply with European Commission Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) and other country and state regulations, please DO NOT dispose of this equipment in any location other than designated locations.

Section 4: Device Description 20 of 96 Section 4: Device Description 1.1 Rear Panel Power Cord Inlet 100-240V~, 15A, 50-60Hz. Fuse Holder Rating is T 6.3A, 250V. Replace fuses if needed, only with fuses having exactly the same rating. Software Flash Memory Plug The software plug is a flash memory with the machine software. The software plug should be screwed to the connectors. To tighten and/or loosen the screws use fingertips only. Do not use screwdriver as it can damage the connectors. Footswitch Connector The Footswitch is connected to the inlet. Footswitch activates RF energy if the System is in Ready mode. Place the Footswitch on the floor near the treatment area. RF Handpiece Connector Located on the upper right side of the Rear Panel and connects to one of RF Handpieces (Fractora, Forma and Plus – upper Connector) , or to BodyFX/MiniFX – lower Connector) through two types of Connectors. Additional Features Interlock Connector ! 

Section 4: Device Description 21 of 96 -1: Two RF Connectors on the Rear Panel (Arrows)4Figure 1.1 Front Panel and Operator Control Panel The Operator Control Panel is located on the upper side of the System. The Operator Control Panel consists of an LCD touch screen with four buttons. 4Figure -2: Front Panel and Operator Control Panel with Optical Handpiece Connector (Arrow) Power On-Off Switch The Power Switch turns the System on and off. The Switch is located on the Front Panel. Optical Handpiece Connector Located in the center of the front panel and connects to one of the optical Handpieces.

Section 4: Device Description 22 of 96 Emergency Stop Button Stops the power instantly in emergency conditions. LCD Screen The LCD screen shows information about the System mode and treatment parameters. The Panel allows changing treatment parameters and System mode. Power electronics is not activated if no Handpiece is connected to its Connector on the Front or the Rear Panel. The System recognizes the connected Handpiece and enables opening only the relevant screen, except for Fractora and Forma/Plus that have to be chosen manually on the interface. 1.1 Software Screens The Splash Progress Screen appears after the On-Off Switch is turned on. -3: Splash Progress Screen4Figure *The SW version number will be displayed according to the software version. After entering the individual code on the Login Screen, non-authorized use of the device is prevented.

Section 4: Device Description 23 of 96 -4: Login Screen4Figure Software is loaded from the plug and self-test of the System modules is performed. After the end of the self-test the Menu Screen appears. -5: Menu Screen4Figure The Menu Screen allows the selection of the connected Handpiece, or entry to the Utilities Screen.

Section 4: Device Description 24 of 96 -6: Utilities Screen4Figure The Utility Screen contains: Volume This function allows the user to adjust the System volume. Drain/Fill Water Drain water from the Handpiece (Diolaze, DiolazeXL and Lumecca only) and device prior to shipment and fill water during installation. Change Password Change the password by entering the old password and then entering another 4-digit password. Calibration External validation module for optical Handpieces –Diolaze, DiolazeXL and Lumecca. Main Menu Return to the Main Menu to select the Handpiece. After returning to the Menu Screen and choosing the application on the Menu Screen the corresponding Treatment Screen appears. Pressing the DIODE icon on the Menu Screen will open and the Diolaze or DiolazeXL Treatment Screen will open according to the attached handpiece.

Section 4: Device Description 25 of 96 -7: Diolaze/DiolazeXL Treatment Screen4Figure The Dioalaze/DiolazeXL Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Fluence: Fluence (light energy density) is changed within the limits from 15 to 60J/cm² for Diolaze and from 5 to 40J/cm² for Diolaze XL, and the System starts up at the minimal setting. Cooling Normal and Strong cooling, 10 and 2oC, respectively, can be selected for Diolaze and 12 and 7oC for Diolaze XL. Pulse Width Short or Long pulse can be selected. Pulse Mode Pps= Pulse Per Screen For Diolaze Off - Single, Normal – 0.5pps, and Fast – 1pps For DiolazeXL: Off – Single 5-40J/cm2 1pps 5-40J/cm2 2pps 5-25J/cm2 Glide 5-10J/cm2 Counter Reset The Pulse Counter can be reset. Pulse Counter Shows the number of pulses delivered from the beginning of the treatment.

Section 4: Device Description 26 of 96 System Mode The System has four treatment modes: Standby mode: allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. Armed mode: when the Footswitch is pressed, before the Hand Trigger. Ready mode: when the System is waiting for a signal from the Trigger Switch to activate the energy. Any attempt to change the treatment settings switches the System to Standby mode. Active mode: when the laser is pulsed by pressing the Hand Trigger. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed. -8: Lumecca 580 Treatment Screen (same screen for the 515)4Figure The Lumecca 580 or 515nm Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Fluence: Fluence (light energy density) is changed within the limits from 5 to 30J/ cm² for Lumecca and the System starts up at the minimal setting. Cooling Normal and Strong can be selected. Pulse Width Short or Long can be selected.

Section 4: Device Description 27 of 96 Pulse Mode Repeat mode in Normal or Fast repetition rate or in Off as a single pulse mode. Counter Reset The Counter can be reset. Pulse Counter Shows the number of pulses delivered from the beginning of the treatment. System Mode The interfaces have three treatment modes. Standby, Ready, and Active. Standby mode allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. In Ready mode, the system is waiting for a signal from the Trigger Switch to activate the energy. Any attempt to change the treatment settings switches the system to Standby mode. When the signal from the trigger is indicated, the System switches to Active mode. Any attempt to change the treatment settings switches the System to Standby mode. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed. -9: Fractora Treatment Screen4Figure The Fractora Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Tip Type Allows selecting between different tip types of Fractora. Energy Delivered energy is changed from level 5 to 62 energy levels and the System starts up at the minimal energy setting.

Section 4: Device Description 28 of 96 Pulse Mode Allows choosing between single pulse and pulse trains ranging from 0.5 to 2 pulses per second (pps). Counter Reset The Counter can be reset. Pulse Counter Shows the number of pulses delivered on one zone, and the total number of pulses from the beginning of the treatment. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed. System Mode The System has three treatment modes: Standby, Ready and Active. Shows number of pulses delivered on one zone and total number of pulses from the beginning of the treatment. Return to Main Menu to select another Applicator and change the Applicator if needed. The System has three treatment modes: Standby, Ready, and Active. Standby mode allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. In Ready mode, the System is waiting for a signal from the Footswitch to activate the energy. Any attempt to change the treatment settings switches the System to Standby mode. When the signal from the Footswitch is indicated, the System switches to Active mode. Any attempt to change the treatment settings switches the system to Standby mode. -10: Forma/Plus Treatment Screen4Figure

Section 4: Device Description 29 of 96 The Forma/Plus Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Applicator Allows selecting between Forma and Plus Handpieces. Energy Delivered energy is changed from level 20 to 62 energy levels and the System starts up at the minimal energy setting. Cut-Off Cut-off temperature settings are changed in the range of 35- 43ºC. When measured skin surface temperature reaches the pre-set limit the RF energy is cut off. Pulse Mode Allows selecting between single RF pulses of 30sec in the Single Mode and continuous RF in Repeat Mode, as long as the Footswitch is pressed. Counter Reset The Counter can be reset. Temperature Measure This indicator shows the skin surface temperature, as measured by an integral temperature sensor. Treatment Time This function shows the total time that RF is activated. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed. System Mode The System has three treatment modes, Standby, Ready, and Active. Standby mode allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. In Ready mode, the system is waiting for a signal from the Footswitch to activate the energy. Any attempt to change the treatment settings switches the system to Standby mode. When the signal from the Footswitch is indicated, the system switches to Active mode. Any attempt to change the treatment settings switches the system to Standby mode.

Section 4: Device Description 30 of 96 -11: BodyFX/MiniFX Treatment Screen4Figure The BodyFX or MiniFX Screen contains: Screen Name The BodyFX or MiniFX is determined by the Handpiece that is connected to the System. Selection Frame The frame selects parameters that can be change by functional keys. Power RF power is changed within the limits allowed for the connected Handpiece. Power level settings are changed from 10 to 50W for BodyFX and from 10 to 25W for MiniFX. The System starts up at minimal power level setting. Cut-Off This indicator shows the Cut-Off temperature, which is adjustable from 35 to 43oC. This indicates measured temperature at which the RF delivery is stopped. Pulse This indicator shows the time period during which vacuum is applied and RF energy is delivered, which is adjustable from 2 to 7sec for BodyFX and from 1-5sec for MiniFX. Counter Reset The Treatment Time can be reset. Temperature Measure This indicator shows on line the skin surface temperature, with a maximal Temperature of 43oC. Vacuum Level This indicator shows on line the negative pressure applied by the vacuum. Total Time This indicator shows the total time of RF delivery. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed. System Mode The System has three treatment modes, Standby, Ready and Active.

Section 4: Device Description 31 of 96 Standby mode allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. In Ready mode, the system is waiting for a signal from the Footswitch to activate the energy. Any attempt to change the treatment settings switches the System to Standby mode. When the signal from the Footswitch is indicated, the System switches to Active mode. Any attempt to change the treatment settings switches the System to Standby mode. 1.1 Sound Indicator Periodic beeping signal is emitted, when energy is delivered.  A warning sound tone indicates Bad Coupling.  1.2 Cut-Off Temperature Control The cut-off temperature up to an upper limit of temperature of 43oC is constantly maintained for Forma/Plus, and BodyFX/MiniFX handpieces. When the measured temperature approaches the Cut-off Temperature, the tone beeps double in speed. It becomes faster when the Cut-off Temperature is reached and RF is instantly inactivated. As soon as the temperature drops below the Cut-off temperature, RF starts again, thus maintaining the desired temperature with safety and when reached, RF delivery is automatically stopped. Temperature is monitored by a temperature sensor in the Handpiece and serves as a safety feature 1.2 Handpieces Each Diolaze and DiolazeXL Handpiece comprises an Applicator, Cable and Connector. -12: Diolaze (Left) and DiolazeXL (Right) Handpiece4Figure

Section 4: Device Description 32 of 96 The DiolazeXL Handpiece contains: Applicator Diolaze comprises diode laser with linear scanning system, cooled sapphire output window (8 x 50mm), and electronic shutter. DiolazeXL diode laser (the bars vary according to wavelength – 810, alternate 810 and 1064, and alternate 755 and 810nm). There is a cooled sapphire output window (11X27.5mm), and -12).4electronic shutter (Figure Cable Has a length of 170cm (67”) Connector The Connector is connected to the System. Each of the Lumecca Handpieces (515 and 580) comprises an Applicator, Cable and Connector. -13: Lumecca Handpiece4Figure The Lumecca Handpiece contains: Applicator Comprises flash lamp and reflector emitting optical energy -13). 4through the pre-cooled light guide (30x10mm) (Figure Cable Has a length of 170cm. Connector The Connector is connected to the System. 4The Fractora Handpiece comprises an Applicator, Cable and Connector (Figure -14). 4Single use tip is connected to the groove in the handle before each use (Figure -15). The tip is connected or disconnected by pull or push movement.

Section 4: Device Description 33 of 96 -14: Fractora Handpiece4Figure The Fractora Handpiece contains: Handle The Handpiece handle is made of metal and has ergonomic design for easy treatment with high visibility of the treated area -14).4(Figure Cable Has a length of 280cm (110’’). Connector The Connector is connected to the System Control Panel. Tips -15). 4Handpiece tips have 2 sizes of pin arrays (Figure 60 pins are 600µ long, and 24 pins are 2500µ long. -15: Fractora Tips: Left 60 pin; Right 24pin (Coated/Non-coated)4Figure Forma/Plus Handpieces comprise an Applicator, Cable, Connector and an integral Temperature Sensor. -16: Forma Handpiece4Figure

Section 4: Device Description 34 of 96 -17: Plus Handpiece4Figure The Forma/Plus Handpieces contain: Tip Is a part of the Handpiece, comprising RF Electrodes and Temperature Sensor. Handle Is made of metal and has ergonomic design for easy treatment with high visibility of the treated area. Cable Has a length of 280cm (110’’). Connector The Connector is connected to System Rear Panel. BodyFX/MiniFX Handpiece comprise a Vacuum Chamber, 2 RF Electrodes, Temperature Sensor, 8-character Screen, Handle, Cable and Connector. -18: BodyFX Handpiece4Figure -19: MiniFX Handpiece4Figure

Section 4: Device Description 35 of 96 The BodyFX/MiniFX Handpieces contain: Handle The Handpiece Handle is made of plastic and has ergonomic design for easy treatment with high visibility of the treated area. Vacuum Cleaner Applied to the skin surface and shape the skin for optimal heating. RF Electrodes Located in the Vacuum Chamber and delivers RF energy to the treated tissue. Screen Shows the measured temperature. Cable Has a length of 280cm (110’’). Connector The Connector is located on the System Rear Panel. Temperature Sensor Located in the Vacuum Chamber for the skin temperature measurement.

Section 5: System Operation 36 of 96 Section 5: System Operation This section of the manual explains how to start the device, operate it, and turn it off. Prior to using or connecting the Handpiece, inspect the System and Handpiece for possible mechanical damage. 2.1 Device Start-Up .1 Connect the Handpiece to the Handpiece Connector Socket on the System. .2 Turn on the Main Power Switch on the Rear Panel. .3 Press the On-Off button on the Control Panel to turn the device on. The System loads the software and enters the Menu Screen. .4 Enter a unique password to get access to the device. If the password is correct, the System enters the Menu Screen. .5 The System loads the software and enters a self-test mode. If any problem is detected during the test the error message will appear (See the Troubleshooting section in this manual). If the test is passed correctly, then the System automatically enters the Menu Screen. .6 Select Application from the Menu Screen and the System will enter the Treatment Screen. .1 Verify on the screen that the software version is properly displayed, and that the connected Handpiece type is recognized correctly. .8 Select the treatment parameters using Up and Down arrow keys. .1 Apply the Handpiece to the treated area, ensuring a full contact. .11 Press the Standby icon that will change to Ready. .11 To start treatment, press the Footswitch for RF applicators, press the Hand- Trigger button for IPL applicators, and press the Footswitch followed by the Hand-Trigger press for laser applicators. The following information is related to the Diolaze and DiolazeXL lasers only. .12 The Cooling Down icon may appear and when the target temperature is achieved, the icon will change to Standby. If cooling is fast enough, the Standby icon will appear immediately. – If the laser is not activated within 3 minutes, the System will go back to Standby mode. – After pressing the Footswitch, the icon will change to Armed.

Section 5: System Operation 37 of 96 – After pressing the Hand Trigger as well, the icon will change to Trigger, and the laser can be emitted to start the treatment. .13 Lasing is apparent by the blue LED running around the window in the Handpiece, and by an audio signal. .14 During treatment, when the laser lightguide is heating up, the System will go into Cooling Down mode. Wait until the icon changes to Standby mode, as no energy is delivered in Cooling Down Mode. Press the Standby icon to resume Ready mode. 2.1 System Shutdown To shut down the System, turn the On-Off Switch located at the front to Off.  Turn the Main Power Switch to Off at the end of the day. 

Section 6 – Diolaze Treatment Information 38 of 96 Section 6 – Diolaze Treatment Information Diolaze hair removal treatment is based on principles of selective photothermolysis. The light penetrates into the skin and is selectively absorbed by melanin of the hair shaft. The absorbed energy is converted into heat, coagulating the hair follicle. Multiple treatments are required for best results. Light blond and white hairs, as well as villous hairs are resistant to the treatment due to scares pigmentation in the hair shaft. 2.1 Indications for Use The Diolaze Handpiece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. 2.1 Contraindications  Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles. Pregnancy and nursing.   Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.   Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction, polycystic ovary and hormonal virilization. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.  Known skin photosensitivity or using drugs increasing skin photosensitivity.  Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria. 

Section 6 – Diolaze Treatment Information 39 of 96  Certain delay is recommended if other recent treatments like light, laser or RF were performed on the same area.  Lasers can cause increased hair growth in some individuals with the highest risk groups for being females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck. Fresh tan from sun, sunbeds or chemicals.  Vitiligo.   As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient. Do not treat the upper eyelids and the lips! Do not treat over tattoo and permanent makeup! 2.1 Possible Adverse Effects Possible adverse effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), in-growing hairs and scarring. Peri-follicular erythema and edema lasting for a few days after the treatment is a desirable typical treatment end point. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck. 2.1 Pre-treatment Recommendations During the patient’s first visit the treating attendant should: Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications. 

Section 6 – Diolaze Treatment Information 40 of 96  Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. Instruct the patient about the safety warnings.   Advise the patient to avoid skin irritation or skin tanning. Sunscreen is advisable during outdoor activity at daylight hours.  The patient should discontinue any irritant topical agents for 2-3 days prior the treatment. Stop anticoagulants 7-10 days prior to treatment, if medically permitted.  Photograph the patient.  Mark the treatment area with a white marker.  Clean the Handpieces parts that come in contact with the skin with 70% alcohol.  Treatment area should be shaved prior the treatment. Hairs may absorb light and leave burn mark on the skin. 2.2 Tip Cleaning Instructions Prior to Use Clean the Handpiece output window with 70% alcohol absorbed pad for at least 30sec and dry completely. 2.2 Treatment Recommendations .1 Follow Device Start-Up Procedure from System Operation section. .2 Shave the treatment area and ensure that skin is clean. .3 Apply thin layer of water based gel to the treated area. Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date. .4 Make a test-spot with Normal/Weak Cooling to see epidermal end-points of perifollicular erythema/edema. Change to Strong Cooling while treating for better comfort and safety. Perform the test spot in the area to be treated in a non-conspicuous site and wait according to the Table below to check the response.

Section 6 – Diolaze Treatment Information 41 of 96 .5 Set treatment parameters. Typical treatment parameters are shown in the table here: Skin Type Fluence [J/cm2 ] Pulse Width Cooling Max. Speed I 30-40 Test - Wait at least 15-30 min. increase or decrease by 2-5 J/cm2 Short Strong/Medium/ Weak Fast II 25-40 Test - Wait at least 15-30 min. increase or decrease by 2-5 J/cm2 Short Strong/Medium /Weak Fast III 20-40 Test - Wait at least 15-30 min. increase or decrease by 2-5 J/cm2 Short Strong/Medium Fast IV 20-35 20-40 Test - Wait at least 15-30 min. increase or decrease by 2-3 J/cm2 Short Long Strong/Medium Fast V 15-35 Test - Wait at least 2- 3 days. increase or decrease by 2-3 J/cm2 Long Strong Fast/N ormal VI 15-25 Test - Wait at least 2- 3 days. Increase or decrease by 1-2 J/cm2 Long Strong Normal For longer cooling .6 Always start with a low settings level to check patient tolerance, test, watch epidermal response, and increase or decrease settings gradually. Darker skin is safer to treat with long pulse width. Lighter hair requires higher fluence to

Section 6 – Diolaze Treatment Information 42 of 96 reach the results. Stronger cooling allows better epidermis protection, but may compromise results on very superficial hair e.g. upper lip or Asian skin in general. Reduce fluence on thin skin and in bone proximity along with a thicker layer of gel. Consider primarily safety for selection of parameters. .1 Apply Handpiece to the treated area ensuring a contact with pressure, and press trigger button to deliver Diolaze laser pulse. During one application, the scanner covers the full length of the output window. .8 Move Handpiece to adjacent area in the pause between laser pulses, indicated by audio signal and blue light. Do not overlap and apply next pulses to cover all treatment area. .1 In a continuous mode - slide the Handpiece to adjacent area without overlap in the time gap between two consecutive lasing events and not while lasing. Chose Auto Repeat Normal or Fast Mode according to the speed of your hand movement. .11 In a single mode (AutoRepeat Off) - move Handpiece by stamping to adjacent area without overlap and apply next pulse to cover all treatment area. .11 If end-points are not obvious, perform another pass, preferably in a different direction, when general erythema subsides. Occasionally, a third pass is applied on light skin. Ensure that there is a delay of a few minutes between passes (after the whole area is treated) before applying additional pass. 2.2 Treatment Schedule The number of treatments is typically varied from 5-10 sessions every 4-8 weeks on the face and 6-12 weeks on the body. Lighter and deeper hair is more resistant and requires more treatment sessions. Hair re-growth should be observed prior the treatment. Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. 2.2 Post Treatment Recommendations Following each treatment session, the physician should advise the patient on proper care. Sun block should be used for 3 weeks following the treatment.  Moisturizer may be applied after each treatment.  Make-up may be applied immediately after facial treatment. 

Section 7: DiolazeXL Treatment Information 43 of 96 Section 7: DiolazeXL Treatment Information DiolazeXL hair removal treatment is based on principles of selective photothermolisys. The light penetrates into the skin and is selectively absorbed by melanin of the hair shaft. The absorbed energy is converted into heat, coagulating the hair follicle. Multiple treatments are required for best results. White hairs are resistant to the treatment due to scares pigmentation in the hair shaft. DiolazeXL 810 is a universal hair removal for all skin types. However, blond hair and fine hair respond better to the DIiolazeXL 755/810, while DiolazeXL 810/1064 is more suitable for very dark skin and deep hair. 2.1 Indications for Use The InMode System with the DiolazeXL Handpieces is intended for hair removal. 2.1 Contraindications  Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.  Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles. Pregnancy and nursing.   Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.  Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. Severe concurrent conditions, such as cardiac disorders, sensory disturbances. 

Section 7: DiolazeXL Treatment Information 44 of 96 Use of Isotretinoin (Accutane®) within 6 months prior to treatment.  Known skin photosensitivity or using drugs increasing skin photosensitivity.  Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.   Certain delay is recommended if other recent treatments like light, laser or RF were performed on the same area. Fresh tan from sun, sunbeds or chemicals.   Lasers can cause increased hair growth in some individuals with the highest risk groups for being females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck. Vitiligo.   As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient. Do not treat the upper eyelids and the lips! Do not treat over tattoo and permanent makeup! 2.1 Possible Adverse Effects Possible adverse effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), in-growing hairs and scarring. Peri-follicular erythema and edema lasting for a few days after the treatment is a desirable typical treatment end point. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Section 7: DiolazeXL Treatment Information 45 of 96 2.1 Pre-Treatment Recommendations During the patient’s first visit the treating attendant should: Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications.   Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. Instruct the patient about the safety warnings.   Advise the patient to avoid skin irritation or skin tanning. Sunscreen is advisable during outdoor activity at daylight hours.  The patient should discontinue any irritant topical agents for 2-3 days prior the treatment. Stop anticoagulants 7-10 days prior to treatment, if medically permitted.  Photograph the patient.  Mark the treatment area with a white marker.  Clean the s parts that come in contact with the skin with 70% alcohol.   The treatment area should be shaved prior the treatment. Hairs may absorb light and leave burn mark on the skin. 2.2 Tip Cleaning Instructions Prior to Use Clean the output window with 70% alcohol absorbed pad for at least 30sec and dry completely. Leave it for complete drying. 2.2 Treatment Recommendations .1 Follow Device Start-Up procedure from the System Operation section. .2 Ensure that skin is clean. .3 Apply a thin layer of water-based gel to the treated area

Section 7: DiolazeXL Treatment Information 46 of 96 Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date. .4 Make a test-spot with Normal/Strong Cooling to see epidermal end-points of perifollicular erythema/edema. Change to Strong Cooling while treating for better comfort and safety. Perform the test spot in the area to be treated in a non-conspicuous site and wait according to the Table below to check the response. .5 Test and wait at least 15-30 min and increase or decrease by 2-5 J/cm2 for skin types I-IV. Wait 2-3 days and increase or decrease by 1-2J/cm2 for skin types V- VI. .6 Set treatment parameters. Typical treatment parameters are shown in the table below; however, an individual adjustment is required: Skin Type Fluence [J/cm2 ] Pulse Width Cooling 755/810 810 810/1064 I 15-30 16-30 18-30 Short Strong/Normal II 12-25 14-28 16-30 Short Strong/Normal III 10-20 12-25 14-25 Short Strong/Normal IV 10-20 12-25 14-25 Long Strong/Normal V 6-15 10-20 12-22 Long Strong VI NA 8-16 10-20 Long Strong .1 Always start with a low settings level to check patient tolerance. Test, watch epidermal response, and increase or decrease settings gradually. Darker skin is safer to treat with Long pulse width. Lighter hair requires higher fluence to reach the results. Stronger cooling allows better epidermis protection but may compromise results on very superficial hair e.g. upper lip or Asian skin in general. Reduce fluence on thin skin and in bone proximity along with a thicker layer of gel. Consider primarily safety for selection of parameters. .8 Apply to the treated area ensuring a contact with pressure, depress Footswitch and press trigger button to deliver DiolazeXL laser pulse. .1 Move to adjacent site with small overlap and apply next pulses to cover all treatment area. Pulse Mode may vary from Off (single pulse) or 1, 2 pulses per second (pps) and Glide (5 pps), restricted by certain fluence, as described in Device Description in Section 4. .11 In a continuous mode – choose Pulse Mode of 1, 2 or Glide 5 pps according to the speed of your hand movement and slide the Handpiece to adjacent site.

Section 7: DiolazeXL Treatment Information 47 of 96 .11 In a single mode (Pulse Mode at Off) - move Handpiece to adjacent site and apply next pulse to cover all treatment area. .12 If end-points are not obvious, or if gaps are apparent, perform another pass, preferably in a different direction, when general erythema subsides. Occasionally, a third pass on selected sites is applied on light skin. Ensure that there is a delay of a few minutes between passes (after the whole area is treated) before applying additional pass. 2.2 Treatment Schedule The number of treatments typically varies from 4-10 sessions every 4-8 weeks on the face and every 6-12 weeks on the body. Lighter and deeper hair is more resistant and requires more treatment sessions.  Hair re-growth should be observed prior the treatment.   Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. 2.2 Post-Treatment Recommendations Following each treatment session, the physician should advise the patient on proper care. Sun block should be used for 3 weeks following the treatment.  Moisturizer may be applied after each treatment.  Make-up may be applied immediately after facial treatment.  During the first 2 days following treatment, care should be taken to prevent  trauma to the treated area: avoid hot baths, massage, etc. The skin should be kept clean to avoid contamination or infection. Any mechanical or thermal damage to the area must be avoided.

Section 8: Lumecca Treatment Information 48 of 96 Section 8: Lumecca Treatment Information IPL Lumecca treatment is based on principles of selective photothermolysis. The light penetrates into the skin and is selectively absorbed by lesion chromophore (melanin or hemoglobin) having darker color than surrounding tissue. Absorbed energy is converted into heat, coagulating the lesion which fades during a few weeks following the treatment. Fine textural lesions like macro-pores, and fine lines may improve along with the pigmented and vascular lesions in the skin photo-rejuvenation process. Multiple treatment sessions may be required for best results. 2.1 Instructions for Use The Lumecca Handpieces are intended for treatment of superficial vascular and pigmented lesions on skin type I to IV. 2.1 Contraindications  Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.  Pregnancy and nursing.  Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.  Severe concurrent conditions, such as cardiac disorders, sensory disturbances.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Use of Isotretinoin (Accutane®) within 6 months prior to treatment.  Certain delay is recommended if other recent treatments such as light, laser or RF were performed on treated area.  Known skin photosensitivity or using drugs increasing skin photosensitivity.  Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.

Section 8: Lumecca Treatment Information 49 of 96  Vitiligo.  Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning creams and sprays within the last two weeks.  As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient. Do not treat the upper eyelids and the lips! Do not treat over tattoo and permanent makeup! Permanent hair reduction may occur in the treated area. Do not treat over an area with a high density of hair. Absorption of light by hair follicles may cause an adverse skin reaction. 2.1 Possible Adverse Effects Possible adverse effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), and scarring. Erythema, lasting not longer than 24h is a typical skin reaction to the Lumecca treatment. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. 2.1 Pre-Treatment During the patient’s first visit the treating attendant should: Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications.   Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort.

Section 8: Lumecca Treatment Information 50 of 96 Instruct the patient about the safety warnings.   Advise the patient to avoid skin irritation or skin tanning for at least 2 weeks. Sunscreen is advisable during outdoor activity at daylight hours.  Patient should discontinue any irritant topical agents for 2-3 days prior the treatment. Stop anticoagulants 7-10 days prior to treatment, if medically permitted.  Photograph the patient.  Mark the treatment area.  Clean the handpieces parts that come in contact with the skin with 70% alcohol.   The patient may shave the area to be treated. Long and dark hair may absorb light and leave burn mark on the skin. 2.2 Tip Cleaning Instructions Prior to Use Clean the light guide with 70% alcohol absorbed pad for at least 30 sec.  Leave it for complete drying.  2.2 Treatment Recommendations .1 Follow Device Start-Up Procedure from System Operation section. .2 Ensure that skin is clean. .3 Apply thin layer of water-based gel to the treated area. Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date. .4 Set treatment parameters. Reduce ~20% fluence on thin sensitive skin like neck or bony area like forehead. Further reduce fluence on thin sensitive skin over bone like chest and hand dorsum and on off-face, body areas, as well as on off-face areas, such as arms and legs. .5 Typical treatment parameters are shown in the table below:

Section 8: Lumecca Treatment Information 51 of 96 Skin type Lesions type Handpiece Fluence Pulse width Cooling I-II Pigmented lesions 515nm 8- 12J/cm² Short Long Strong Vascular lesions 515nm 12- 16J/cm² Short Long Strong III-IV Pigmented lesions 580nm 6- 12J/cm² Short Long Strong Vascular lesions 580nm 10- 16J/cm² Long Strong .6 Always start with a low settings level to check patient tolerance to the treatment parameters, test and then gradually increase energy fluence to reach the results without compromising safety. .1 Apply the Handpiece to the treated. Use slight pressure and activate the Hand Trigger Button to deliver a light pulse. .8 Perform a test spot in the area to be treated on a non-conspicuous spot and wait 10-15 minutes to check the response. .1 In a single mode (AutoRepeat Off) - move Handpiece to adjacent area without overlap and apply next pulse to cover all treatment area. .11 In a continuous mode - slide the Handpiece to adjacent area without overlap and chose Auto Repeat Normal or Fast Mode according to the speed of your hand movement. .11 If end-points of darkening lesions and inflammation around them are not obvious after a few minutes, perform a second pass, preferably in a different direction. Lumecca is a very powerful Applicator. Take care with treatment parameters! 2.2 Post-Treatment Recommendations After each treatment session, the physician should advise the patient on proper care. Sun block should be used for 3 weeks following the treatment.  Moisturizer and make-up may be applied immediately after each treatment. 

Section 8: Lumecca Treatment Information 52 of 96 2.2 Treatment Schedule The number of treatments typically varies from 2-5 sessions every 3-4 weeks. Pigmented lesions usually require less sessions than vascular lesions. Treatment should be concluded when the results are satisfactory to the patient or at the discretion of the physician.

Section 9: Fractora Treatment Information 53 of 96 Section 9: Fractora Treatment Information 2.1 Fractional Skin Resurfacing The Fractora Handpiece is designed for delivering RF energy to the skin surface in a fractional manner with the energy applied to <10% of the total coverage area. The energy is delivered to the skin through bipolar arrays of pins and results in localized heating and ablation of the skin that is in direct contact with the pins. Ablation of the skin promotes skin resurfacing while untreated skin between the pins promotes faster healing of the tissue. There is also the contribution of non-ablative, non- coagulating dermal matrix heating that occurs in the skin that is not subject to fractional ablation. 2.1 Instructions for Use The InMode System with the Fractora Handpiece is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. 2.1 Contraindications  Pacemaker or internal defibrillator, or other metallic or electronic implant anywhere in the body. The Handpiece should be used at least 1cm away from cochlear implants in the ear.  Permanent implant in the treated area such as metal plates, screws and metal piercing or silicon, unless deep enough in the periosteal plane.  Intra-dermal or superficial sub-dermal areas injected with Botox®/HA/collagen/fat injections or other augmentation methods with bio- material, before the product has been dissipated (up to 6 months), except Botox after binding to the facial muscles (3-7 days). It is possible to treat sooner over injectable products placed in the deep, periosteal plane, as soon as the area has healed (1-3 weeks).  Current or history of skin cancer, or any other type of cancer, or pre-malignant moles. Pregnancy and nursing.  Severe concurrent conditions, such as cardiac disorders or sensory disturbances.   Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.

Section 9: Fractora Treatment Information 54 of 96  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. History of bleeding coagulopathies.  Any facial surgery performed within a year prior to treatment.   Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. Having received treatment with light, laser, RF, or other devices in the treated  area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.   Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner’s discretion. Treating over tattoo or permanent makeup.  Treating over the lips.  Treating over eyebrows or other hair bearing surfaces.  Skin type VI and dark V patients treat with caution.   Excessively tanned skin from sun, tanning beds or tanning creams and sprays within the last two weeks.  As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.

Section 9: Fractora Treatment Information 55 of 96 2.1 Possible Adverse Effects Possible adverse effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), and scarring. Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin reaction to the Fractora treatment. Crusting from the ablated dots will exfoliate naturally after 1-3 weeks. Occasionally, at energy levels >30-40 energy levels, there is a potential low-level stimulation of branches of the facial nerve and there will be some involuntary contraction of the underlying facial muscle. This is transient and is not harmful, as the Fractora effect diminishes at the deeper level where parts of the facial nerve lie above the muscles. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. 2.2 Pre-Treatment Recommendations During the patient’s first visit the treating attendant should: Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications.   Determine why the patient is seeking treatment and what his/her expectations are. Determine accurately the patients Fitzpatrick skin type.   Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. Instruct the patient about the safety warnings.   Advise the patient to avoid skin irritation or intentional skin tanning. Sunscreen is advisable when outdoors during daylight hours. Asian patients and skin type IV-V should be treated gradually by bleaching  products 6 weeks prior treatment and stop at least 48 hour prior Fractora treatment to minimize risk of post inflammatory hyper-pigmentation.  Prophylactic antiviral therapy should be prescribed for patients with history of cold sores (Herpes Simplex) when treating around the mouth.

Section 9: Fractora Treatment Information 56 of 96 Stop anticoagulants 7-10 days prior to treatment, if medically permitted.  Clean the treatment area.  Apply anesthesia:  – Many patients can tolerate the treatment with no anesthesia at low energy levels of 5-20 energy levels and sometimes more. – Topical for 30-45 min – limited to energy as tolerated by the patient and may reach 40-62 energy levels, depending on the percent numbing ingredients and patient sensitivity. – A few patients require nerve block for higher energy, limited to central face. – Tumescent or IV sedation is applied usually when Fractora follows an invasive procedure.  The patient should shave the area to be treated. Long and dense hairs prevent electrode contact with the skin’s surface 2.2 Tip Cleaning Instructions Prior to Use Clean the tip with 70% alcohol absorbed pad for at least 30sec.  Leave it for complete drying.   Before each use of the Fractora Handpiece and tip, they must be checked for integrity and proper cleaning and drying.  The Fractora tip is single use only. 2.2 Test Spots A small test spot should be performed in a non-conspicuous area of the treatment site, prior to the first complete session. Test spot is performed to establish the following requirements: Confirm the patient's suitability for treatment:  – For skin type I – III wait 10-15 minutes before assessing the skin response. – For skin types IV-V wait 2-3 days if energy level <30 is used and 7-10 days for energy level >30, due to delayed response of dark skin.

Section 9: Fractora Treatment Information 57 of 96  Establish and confirm treatment parameters: if the desired end-point of erythema and edema – in a tip-shaped pattern – has not been achieved within 10-15 minutes, increase the RF energy. If the response is excessive, decrease the parameters.  Tolerance of patient to the treatment: low energy levels of 10-25 may be tolerated after topical anesthesia application. Energy levels of 25-40 may require nerve block or tumescent and high energy levels of 40-62 may call for tumescent or IV sedation. 2.2 Treatment Recommendations .1 Apply the necessary means of anesthesia. If topical, make sure that it is cleaned off the face before treatment and the skin is dried with alcohol 70%. .2 Ensure that skin is clean and dried with alcohol 70%. .3 Take an alcohol cleaned and dry tip and connect it to the Handpiece in the groove. .4 Connect Handpiece to the system. .5 Follow Device Start-Up Procedure from System Operation section. .6 Set treatment parameters. Typical treatment parameters are shown in the table below: Clinical Indications Tip Treatment Area RF Energy Level Number Sessions Weeks between Sessions Down Time Days Superficial - texture, tone, very fine lines 60 Soft tissue 10-25 3-5 1-4 0-1 Bony area 5-20 Moderate - texture, tone, fine lines 60 Soft tissue 25-30 2-3 4-5 2-3 Bony area 20-30 Deep - texture, tone, fine lines, fine vessels, wrinkles, acne scars 60 Soft tissue 30 1-2 5-6 7-10 Bony area 03-52

Section 9: Fractora Treatment Information 58 of 96 Clinical Indications Tip Treatment Area RF Energy Level Number Sessions Weeks between Sessions Down Time Days Deep wrinkles, scars 24 Soft tissue 25-50 1-3 3-6 2-5 Deep wrinkles, scars 24 Bony area 20-30 1-3 3-6 1-2 Lax skin and dark skin ablation 24 Coated Soft tissue dark skin up to VI 15-40 1-2 2-3 2-5 Lax skin and dark skin ablation 24 Coated Bony area dark skin up to V 15-25 1-2 2-3 1-2  The approval and availability of the various Fractora tips may differ in different countries. .1 Always start with a low energy level, test and observe the skin's response before increasing the energy. .8 The deeper the lesion, the higher the energy. However, this consideration is limited according to patient tolerance, the anesthetic method used, and the affordable down time. .1 On sensitive thin skin area, such as lower eyelid, apply lower parameters with more passes, rather than higher parameters in one pass. It is also applicable to any facial area for new users. Use lower energy (~20%) for thin skin like neck or bony area like forehead. When working on thin skin over bone, such as hand dorsum or chest, further reduce energy (~20%). .11 Do not use higher energy level than 45 energy levels for soft tissue of dark skin IV-V and reach it gradually in 3-5 sessions with 5 energy levels increments each session. On bony area of dark skin restrict energy, reaching highest energy level of 25 energy levels. .11 Apply the Fractora Handpiece to the treated area ensuring a contact with pressure to minimize discomfort, and press Footswitch to deliver RF energy .12 Move Handpiece to the adjacent area and press Footswitch again in the SINGLE mode, or adjust the repetition rate to the speed you move the tip to adjacent site.

Section 9: Fractora Treatment Information 59 of 96 .13 Move to adjacent areas with no overlapping of side-electrodes (30-50% overlap). .14 Occasionally, additional 1-2 passes may be applied to reinforce results on the full area or on selected spots. Gaps may be treated after the full area is done. When combining 2 tip types on the same area, apply the deeper treatment first and follow with the more superficial treatment. Allow a few minutes between passes to check skin response – the darker the skin, the longer the intervals. .15 The endpoint is substantial erythema and edema, visible ablative craters, and burnt tissue smell often accompanied by tingling heat sensation. 2.2 Treatment Schedule The number of treatment sessions depends on the individual patient and treatment aggressiveness and may vary from 1-5 sessions. Treatments are typically repeated every 3-6 weeks. It is recommended to schedule follow-up session 2-3 days after the treatment to ensure safe healing process. Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. Generally, 3-5 sessions are needed for mild to moderate depth settings. It is not typical to perform more than five consecutive sessions. In some instances, 1-2 sessions may be sufficient. Post-Treatment Recommendations 2.12 After each treatment session, the physician should advise the patient on proper care. Cool the skin for 10-20 minutes.  Emollient cream or occlusive dressing could be applied to the treatment area.   Alternatively, prophylactic antibiotic treatment may be prescribed for 1-3 days post treatment. Patient is to contact the physician if there is any indication of infection, excessive swelling, redness, undue pain, or any other unusual or untoward symptom.  Tiny scabs may appear after 1-3 days and stay for several days following the treatment. The scabs should not be touched or scratched even if they itch, and should be allowed to flake off naturally.  Blisters may be treated with a prescribed antibiotic ointment or burn treatment cream as per physician's discretion.

Section 9: Fractora Treatment Information 60 of 96  During the first two days following treatment the skin should be kept clean to avoid contamination or infection; any mechanical or thermal damage to the area must be avoided.  Prophylactic antiviral therapy should be continued for patients with history of cold sores (Herpes Simplex) when treating around the mouth.  Moisturizer may be applied 24-72 hours after each treatment and then should be applied regularly throughout the course of the treatment. Make-up may be applied only 24-72 hours after each treatment session. Generally, 24 hours after treatment, patients may use regular soaps, but not scrub soaps or exfoliates.  The patient should use a high-factor sunscreen (at least 30 SPF) and protect the treated area from over-exposure to sunlight for at least one month after the treatment, starting 24-72 hours post treatment. Excessive tanning of any sort (sun exposure, tanning beds, and artificial tanning lotions) is not allowed in the treated areas during the entire course of the treatment.  For Asian patients and skin type IV and V, bleaching ointment should be prescribed for 6-12 weeks, 2-3 times a week following the healing of treatment area (typically 7 days) to minimize risk of post inflammatory hyper-pigmentation. It should be stopped 48-72 hours before another Fractora session.

Section 10: Forma/Plus Treatment Information 61 of 96 Section 10: Forma/Plus Treatment Information Instructions for Use 12.1 The InMode system with the Forma Handpiece is intended for use in dermatologic procedures for noninvasive treatment of mild to moderate facial wrinkles and rhytides. The Plus Handpiece is intended for non-invasive and non-ablative treatment of the tissue to trigger collagen remodeling for the treatment of wrinkles Contraindications 12.1 Pacemaker or internal defibrillator, or any other metallic or electronic implant  anywhere in the body. The Handpiece should be used at least 1cm away from cochlear implants in the ear.  Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.  Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.  Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.  Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases. Pregnancy and nursing.   Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, autoimmune disorders or use of immunosuppressive medications.  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.

Section 10: Forma/Plus Treatment Information 62 of 96  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.  History of bleeding coagulopathies, or use of anticoagulants in the last 10 days, as per the practitioner‘s discretion.  Facial dermabration, laser resurfacing and deep chemical peeling within the last 3 months prior FORMA treatment.  Having received treatment with light, laser, RF, or other devices in the treated area within 3 months, or before complete healing.  Any surgical procedure in the treatment area within the last 3 months or before complete healing. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.   As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient unsafe for the patient Possible Adverse Effects 12.1 Possible side effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, burn), change of pigmentation (hyper- and hypo-pigmentation), scarring. Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. Handpiece Cleaning Instructions Prior to Use 12.1 These cleaning instructions are for clinical use only. The following processes are validated for the InMode Forma/Plus Handpieces when used in accordance with the instructions provided for cleaning products and/or processes. Any deviation from said instructions or the cleaning agents listed below may impact the performance or durability of the product and is prohibited. Review those instructions for additional warnings and cautions. We recommend the usage of the following cleaning agent that was tested in our company for material compatibility as 70% alcohol solution.

Section 10: Forma/Plus Treatment Information 63 of 96 Cleaning Procedure: .1 Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec and repeat as necessary .2 Leave it to dry completely. Pre-Use Check Before each use of the Handpiece, the device must pass the following: .1 Check to ensure proper cleaning and drying of the Handpiece. .2 Inspect all components of the Handpiece for visible damage. Pre-Treatment Recommendations 12.2 During the patient’s first visit the treating attendant should: Complete or update the patient’s medical and physical history  Exclude from treatment anyone with the listed contraindications.   Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. Instruct the patient about the safety warnings.   The patient should discontinue any irritant topical agents for 2-3 days prior to treatment and if medically permitted, anticoagulants should be stopped 1-2 weeks prior treatment. Clean the face, remove crèmes and makeup, and dry the skin.  Photograph the patient.  Mark the treatment area.   Clean the parts of the Handpieces that come in contact with the skin with 70% alcohol.  Long and dense hairs may affect the treatment, and may be shaved according to physician’s discretion.

Section 10: Forma/Plus Treatment Information 64 of 96 Treatment Recommendations 12.2 .1 Ensure that skin is clean and dry. .2 Follow Device Start-Up procedure from Section 5. .3 Set treatment parameters. Suggested facial treatment parameters for Forma are shown in the table below: Facial Treatment Zone RF Energy Level -Off Temperature Cut o[ C] Gel Thick soft skin e.g. Cheeks, nasolabial folds, and jawline 40-50 As high as tolerable Starting at 40oC Thin layer 2-3mm Thin skin e.g. neck 35-40 As high as tolerable Starting at 40oC Thin layer 2-3mm Thin skin over bone e.g. forehead, temples, periorbital 30-35 As high as tolerable Starting at 40oC Thick layer 3-4mm .4 Suggested body treatment parameters for Plus are shown in the table below: Body Treatment Zone RF Energy Level -Off Temperature Cut o[ C] Gel Resistant skin in normal size zone of ~12x12 cm e.g. abdomen, buttocks 40-50 As high as tolerable starting at 40oC Thin layer 2-3mm Resistant skin in small size zone of ~8x8cm e.g. naval area 30-40 As high as tolerable starting at 40oC Thin layer 2-3mm Sensitive skin in normal size zone of ~12x12 cm e.g. Inner thigh 35-45 As high as tolerable starting at 40oC Thin layer 2-3mm Sensitive skin in small size zone of ~8x8cm e.g. Arms, knees 25-35 As high as tolerable starting at 40oC Thick layer3- 4mm

Section 10: Forma/Plus Treatment Information 65 of 96 .5 Any combination of treatment parameters should be according to skin response and patient tolerance. .6 Always start with low settings and observe the skin's reaction and patient comfort before increasing the RF energy. .1 Air condition directed at the patient treated area may reduce the skin surface temperature in 1-2oC, and cut-off temperature should be reduced accordingly. .8 Divide facial and neck treatment area to zones as shown in figure below. Other variations are possible. For smaller neck areas, 2 zones are sufficient. -1: Recommended Forma Facial and Neck Treatment Zones11Figure .1 Treat body areas by zones with size of about 2 hand palms (~12x12cm), such as half of abdominal area, flank, outer thigh, inner thigh, buttocks. When treating smaller zones as upper arm, reduce energy setting to avoid patient discomfort. .11 Apply 2-4mm ultrasound gel (not oil) to the treated zone and to adjacent zone that can serve as a warm gel reservoir for replenishing gel in the treatment zone with minimal delay. Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date. .11 Assume full contact of Handpiece with the skin with a slight pressure. .12 Use your free hand to flatten and stretch treatment area if needed for complete contact and smooth movement. .13 Press the Footswitch and initiate the RF energy. .14 Move the Handpiece in circular movements or back and forth with gentle pressure over the full treated zone to reach uniform skin heating. Movement

Section 10: Forma/Plus Treatment Information 66 of 96 should be constant and its amplitude should be at least double of Handpiece spot size to avoid hot spots. .15 Continue to treat the area in this fashion. Always start with a low setting level to check the patient’s tolerance to the treatment parameters and increase the settings gradually. .16 Apply multiple passes to maintain the desired temperature during ~15-30min on face, neck or on the body (less for smaller zone) . If cut-off temperature is <41oC, maintain the temperature for additional 1-3min per zone. .11 After treating the zone, move to the next zone. .18 For excessive heat sensation, you may increase the movement speed, reduce the RF power and lastly, reduce the cut-off temperature for patient comfort. If this does not help, stop the treatment and move to the next zone. .11 Slight erythema and edema is a typical immediate response. However, when there is excessive skin response (erythema and edema), stop treatment and move to the next zone. For excessive heat sensation, you may increase the movement speed, reduce the RF power and lastly, reduce the cut-off temperature. If this does not help, move to the next zone. The skin should be observed for excessive erythema or edema. If observed, stop the treatment and move to the next treatment zone. Asian skin is typically thicker and more fibrotic than Caucasian skin, hence occasionally higher energy, smaller zones, longer treatment and more sessions (all or part) may be required. Treatment Schedule 12.2 The number of treatment sessions depends on the individual patient and is typically 6 weekly sessions, but can vary according to patient response. Some patients may need only 6 sessions and some 10. Longer treatment time on each zone may reduce the number of sessions. Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. One session every 1-3 months, or as needed, may maintain treatment results. Post-Treatment Recommendations 12.2 Skin cooling is NOT recommended. 

Section 10: Forma/Plus Treatment Information 67 of 96 Patient should avoid very hot water for 2 days after the treatment.  Patient should avoid scrubbing, pinching and etc. of the treated area.   Moisturizer and makeup may be applied to the skin surface immediately post treatment.  After each treatment session, the patient should be advised to contact the physician if there is any indication of infection, excessive swelling, redness, pain, or any other unusual or untoward symptom. The Handpiece should be cleaned from the gel and disinfected by 70% alcohol. 

Section 11: BodyFX/MiniFX Treatment Information 68 of 96 Section 11: BodyFX/MiniFX Treatment Information Indications for Use 11.1 The BodyFX/MiniFX Handpieces are intended for the treatment of the following medical conditions using RF combined with massage:  Relief of' minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.  Temporary improvement of circumferential reduction and body contouring.  Contraindications 11.1  Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.  Permanent implants in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the peri-ostal plane.  Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.  Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.  Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases. Pregnancy and nursing.   Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.

Section 11: BodyFX/MiniFX Treatment Information 69 of 96  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.  History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. History of bleeding coagulopathies.  Any surgery in treated area within 3 months prior to treatment.   Having received treatment with light, laser, RF, or other devices in the treated area within 3 months or before complete healing. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.   As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient. Possible Adverse Effects 11.1 Possible side effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation), scarring, and vacuum bruising. Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment. The patient must understand the importance of pre-treatment and post-treatment instructions and that failure to comply with these instructions may increase the probability of complications. Handpiece Cleaning Instructions Prior to Use 11.1 These cleaning instructions are for clinical use only. The following processes are validated for the BodyFX/MiniFX Handpieces when used in accordance with the instructions provided for cleaning products and/or processes. Any deviation from said instructions or the cleaning agents listed below may impact the performance or durability of the product and is prohibited.

Section 11: BodyFX/MiniFX Treatment Information 70 of 96 We recommend the usage of the following cleaning agent that was tested in our company for material compatibility as 70% alcohol solution. Cleaning Procedure: .1 Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec. .2 Leave it for to dry completely. Pre-Use Check: Before each use of the Handpiece, the device must pass the following: .1 Check to ensure proper cleaning and drying of the Handpiece. .2 Inspect all components of the Handpiece for visible damage. Pre-Treatment Recommendations 11.2 During the patient’s first visit the treating attendant should: Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications.   Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. Instruct the patient about the safety warnings.   The patient should discontinue any irritant topical agents for 2-3 days prior to treatment and if medically permitted, anticoagulants should be stopped 1-2 weeks prior treatment. Photograph the patient.  Mark the treatment area.   Clean the Handpiece with alcohol 70% or other disinfectant. Use alcohol-soaked cotton buds to clean inside the Handpiece cavity.  Long and dense hairs may affect the treatment, and may be shaved according to physician’s discretion.

Section 11: BodyFX/MiniFX Treatment Information 71 of 96 Treatment Recommendations 11.2 .1 Ensure that skin is clean and dry. .2 No gel allowed! .3 Follow Device Start-Up Procedure from Section 5. .4 Set the treatment parameters. Suggested parameters are shown in the table below: Handpiece Treatment Approach RF Power [W] Pulse Width [Sec] Cut-Off Skin Temperature [ºC] BodyFX Sensitive skin 30-40 2 As high as tolerable Starting at 40oC BodyFX Normal skin 35-45 3 As high as tolerable Starting at 40oC BodyFX Resistant skin 40-50 4 As high as tolerable Starting at 40oC MiniFX Sensitive area 10 1-3 As high as tolerable Starting at 40oC MiniFX Normal area 15-20 1-3 As high as tolerable Starting at 40oC MiniFX Resistant area 20-25 1-3 As high as tolerable Starting at 40oC Any combination of treatment parameters should be according to skin response and patient tolerance. .5 Always start with low settings and observe the skin's reaction and patient comfort before increasing the RF power, the temperature or pulse width. .6 Reduce RF Power on thin fat areas and on small areas. When using MiniFX restrict RF Power to 10-20W, occasionally to 25W.

Section 11: BodyFX/MiniFX Treatment Information 72 of 96 .1 Reduce Pulse Width if bruises appear and with MiniFX restrict Pulse Width to 1-3sec. .8 Divide treatment area to zones of about the size of a large hand palm, 4 foot- prints of the Vacuum Chamber (full normal size abdomen = 6 treatment zones), and 3-4 foot-prints for MiniFX. Mark the treatment area and zones. The smaller the zone and the thinner the fat, the lower the RF Power. .1 Assume a full contact of Handpiece with skin with a slight pressure to enable vacuum. .11 Use your free hand to flatten and stretch treatment area. .11 Press the Footswitch and initiate the RF energy and suction, and dwell on the site for preset pulse duration. .12 Move to adjacent site with no overlap from previous site and apply another pulse. .13 15-30 minutes. When skin Apply multiple passes to the treated zone during temperature is <41oC, compensate with 1- 3 more minutes of treatment. .14 Stacking pulses in the first and second passes may shorten the heating time to reach the cut-off temperature. .15 For the next 15-30 minutes, the longer – the better, move around the zone evenly, maintaining cut-off temperature. Please note that time is measured once the cut-off temperature has been reached. .16 Excessive heat sensation after a few passes may call for a faster movement, reduced pulse width, reduced RF power level, and last, reduced cut-off temperature, in this sequence. .11 After 15-30 minutes move to the next zone, usually left or right side, and perform the same steps. .18 Some patients who cannot tolerate the heat may have the treatment time divided into two – e.g. for full 20 minutes total time may be divided to 10 + 10 minutes, allowing the skin to cool down. One zone is then treated for 10 minutes and the other zone (left or right) is treated for 10 minutes. After treating the second zone for 10 minutes return to the first zone and complete additional 10 minutes. Repeat treatment of the second zone. Each zone is treated for a total time of 20 minutes. In odd areas like navel area or neck, allow skin cooling between repeated treatments, especially in small areas. .11 After treating the zone, move to the next zone. Asian skin is typically thicker and more fibrotic than Caucasian skin, hence occasionally higher energy, smaller zones, longer treatment and more sessions (all or part of these measures) may be required.

Section 11: BodyFX/MiniFX Treatment Information 73 of 96 Treatment Schedule 11.2  The number of treatment sessions depends on the individual patient and is typically 8 sessions, once a week. Some patients may get satisfactory results after 6 sessions. Some patients may need 2-4 additional sessions and very few do not respond to treatment. Longer treatment time may help reduce the number of sessions.   Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. One session every 3-6 months, or as needed, may maintain treatment results.  Post-Treatment Recommendations 11.2  Erythema and occasionally purpura is a common response and will subside naturally within a few days. Patient should avoid very hot water for 2 days after the treatment.  Patient should avoid scrubbing, pinching and etc. of the treated area.  Moisturizer can be applied to the skin surface.   After each treatment session, the patient should be advised to contact the physician if there is any indication of infection, excessive swelling, redness, pain, or any other unusual or untoward symptom.

Section 12: System Maintenance 74 of 96 Section 12: System Maintenance Maintenance & Frequency 11.1 The following list suggests how often each of the maintenance procedures should be performed by the operator. Before and after each treatment 11.1 Wipe the device with a damp soft cloth. The Handpiece elements that are in contact with the skin should be disinfected with 70% alcohol between patients, as described in detail for each handpiece in “Handpiece Cleaning Instruction Prior to Use”. For applications that require gel (Diolaze, DiolazeXL, Lumecca, Forma/Plus), remove the gel before cleaning Once a Week 11.1  Clean the System at least once a week. Turn the System off and wipe all surfaces. Be careful not to spill any liquids on the System. Clean the Dust Cover.  Once a Month 11.1 Replace the cooling water at least once a month. Follow the instruction of “Draining Water” and “Filling Water” below. Once a Year 11.2 By the operator:  Replace the Deionizer Cartridge and Capsule Filter at least once a year. Follow the “Replacing the Deionizer Cartridge” and Replacing the Capsule Filter” instructions below.  Replacement Deionizer Cartridge and Capsule Filter can be purchased by your local service center. By authorized service personnel only:  System and Hand pieces full test and calibration is required to be done. Please make sure to contact your local service center to perform this process.

Section 12: System Maintenance 75 of 96 Failure to replace your filters can lead to serious malfunctions of the laser/IPL Handpieces! Filling Water for Diolaze, DiolazeXL and Lumecca 11.2 InMode System, Diolaze, DiolazeXL and Lumecca handpieces are shipped without water. Distilled water must be used and failure to do so will void the service warranty. During water filling, air bubbles can form inside the hoses which may cause water flow issues. This instruction will help prevent this from occurring. .1 Connect one of the Handpieces. .2 Open the back cover and take out the Bottle. .3 -1).12Unscrew the water Bottle Cap (Figure .4 Slowly pour distilled water into the Bottle while the Water Filter and Tube are -2).12inside the Bottle to prevent over pouring (Figure -1: Water Bottle Cap21Figure 21Figure -2: Distilled Water Filling 21Figure -3: Water Bottle in Bracket .5 Fill the Bottle up to the maximum level. .6 Close the bottle cap and insert the Bottle at the back of the System -3).12(Figure .1 Connect any Handpiece to the System. .8 Turn the System On. .1 -4).12Select “Utilities” on the Main Menu (Figure .11 -5).12Select “Water Drain/Fill” from the Utilities Screen (Figure

Section 12: System Maintenance 76 of 96 .11 Pressing the Up arrow will activate the Pump and count down from 600 -6).12seconds (10 minutes) to 0 seconds (Figure -4: Menu Screen21Figure -5: Utilities Screen21Figure -6: Time Counter Water Pump Current Value12Figure .12 After 300 seconds (while the Pump is working), unscrew the plastic Cap on the side of the Capsule Filter counterclockwise to release air. Afterwards, screw -7). Ensure that no water is leaking.12the Cap clockwise to close it (Figure -7: Capsule Filter with Plastic Cap12Figure .13 Pressing the Down arrow will stop the Water Pump. .14 Turn the System Off. .15 Repeat steps 2 to 5 since the System and Handpiece will take some of the water.

Section 12: System Maintenance 77 of 96 .16 If additional Diolaze, DiolazeXL or Lumecca Handpieces are present, connect each Handpiece and repeat steps 6 to14. Ensure the water level is checked periodically. Draining Water for Diolaze, DiolazeXL and Lumecca 11.2 For shipping and storage, the InMode systems and Handpieces must be drained of water during freezing temperature. Failure to do so will void the service warranty. Frozen water in the system and Handpiece hoses can lead to damages. .1 Open the back cover and take out the bottle. .2 Unscrew the water bottle cap and slowly remove it from the bottle (Figure -8).12 12Figure -8: Water Bottle with Deionizer Cartridge -9: Water Bottle in Drain Position12Figure .3 Empty the Bottle. .4 Place the Bottle inside the Chamber with the black hose outside the Bottle -9).12(Figure .5 Connect any Diolaze, DiolazeXL or Lumecca Handpiece. .6 Turn the System On. .1 -4).12-4Figure 12Select “Utilities” on the Main Menu (Figure .8 -5).12Select “Water Drain/Fill” (Figure .1 Pressing the Up arrow will activate the Pump and count down from 600 -6).12seconds (10 minutes) to 0 seconds (Figure .11 Pressing the Down arrow will stop the Water Pump. .11 Repeat Steps 5 to 9 for draining any remaining IPL/laser Handpiece.

Section 12: System Maintenance 78 of 96 .12 Observe the reservoir; when no more water is pouring out, turn off the System. 11.2 Draining the Laser/IPL Handpieces with the Water Draining Tool When only applicators are shipped or stored, follow applicators draining instructions below. It is possible to connect them to the system and perform the draining procedure, as above. It is also possible to use the Invasix Water-draining tool (Figure -10).12 -10: Water Draining Tool12Figure The Diolaze, DiolazeXL and Lumecca Handpieces may be damaged in cold (freezing) temperatures that occur during transportation or the local storage environment. In cold climates, especially during the winter, systems and handpiece may be damaged during transportation or storage when exposed to freezing temperature. To Drain the Handpiece 1. Hold the Water Draining Tool's Connector and insert the Handpiece Connector 12with the label at a 90° counter-clockwise angle (as shown ii Figure -11), and twist it 90° to the right, so that the label is straight. -11: Connecting the Handpiece to the Water Draining Tool12Figure

Section 12: System Maintenance 79 of 96 2. Hold the Handpiece and the Draining Tool over a sink and start pumping air through the Handpiece until no more water drains out. .3 Disconnect the Handpiece from the Water Draining Tool. Damage to the system or Handpieces by frozen water will not be covered under System's warranty.  Only Invasix draining mechanical hand pumps (Invasix P/N AT604837x) could be used to drain Diolaze, DiolazeXL and Lumecca Handpieces. To order the Water Draining Tool, contact our Service department. Replacing the Deionizer Cartridge 11.2 For safety, and proper System performance, replace the cooling water with fresh distilled water only. To remove the Deionizer Cartridge: 1. Drain the water from the System following “Draining Water” procedure. 2. Turn the System Off. 3. Push the Slide Latch of the Bottle Door down, and remove the Door. 4. Holding the Bottle cover with one hand, loosen the Bottle by turning it clockwise. 5. Disconnect the Deionizer Cartridge from the Water Hoses by pressing the -8).12Release Button on the upper part of the Deionizer (Figure To install a new Deionizer Cartridge: .1 Connect the Water Hose into the Deionizer Filter until is securely locked. .2 Remove the Water Bottle from the compartment, pour out the distilled water from the Bottle according to “Draining Water” procedure and wash it with new fresh water. .3 Fill 1 liter of distilled water into the Bottle and return it to its compartment. Perform “Filling Water” procedure as described above.

Section 12: System Maintenance 80 of 96 Replacing the Capsule Filter 11.12 For safety, and proper System performance, replace the cooling water with fresh distilled water only. To remove the Capsule Filter: .1 Drain the water from the System following “Draining Water” procedure .2 Turn the System Off. .3 Push the Slide Latch of the Bottle Door down, and remove the Door. .4 Holding the Capsule Filter with one hand, loosen the Filter by pressing the upper Black Quick Connector and pulling the Filter out of the Water Hose -12 left).12(Figure .5 Holding the Capsule Filter with one hand, loosen the filter by pressing the lower black quick Connector and pulling the filter out of the water hose -12 right).12(Figure -12: Upper (Left) and Lower (Right) Filter Quick Connectors12Figure To install a new Capsule Filter: .1 Hold the Capsule Filter when the arrow on the Filter body pointing upwards. .2 Push the lower System Water Hose into lower Filter’s Quick Black Connector -12right).12as much as possible (Figure .3 Push the upper System Water Hose into upper Filter’s Quick Black Connector -12 left).12as much as possible (Figure .4 Remove the Water Bottle from the compartment, pour out the distilled water from the Bottle according to the “Draining Water” procedure, and wash it with new fresh water. .5 Fill 1 liter of distilled water into the Bottle and return it to its compartment. Perform “Filling Water” procedure, as described above.

Section 12: System Maintenance 81 of 96 Air Filter 11.11 Systems marked by the Service Revisions listed in the table below are equipped with new air filters. The Filters are intended to reduce dust and debris entering and accumulating inside the System. Dust and debris may affect internal heat exchanges and the performance of other components. Platform Description Part Number Service Revision InMode II AG606666A B04 Optimas AG606991A B04 Triton AG606992A A02 -13).12Dust filter are located on inside back over door (Figure -13: Back Cover Door with Dust Filter12Figure Air Filter Maintenance  Dust Filter must be to be cleaned once a week. In dusty environments or desert regions, it should be checked daily. Replace the Dust Filter if damaged.  Cleaning method  Remove back cover door and wash it under tap water until filter net is clean from a dust. Air pressure can used carefully if available. Shake and dry the back-cover door before use.  Return the back-cover door when dry. 

Section 12: System Maintenance 82 of 96 Dust Filter ordering  In order to add a back cover with Dust Filter to existing Systems, order the parts as listed in the table.  For Systems which already have a support for the back door, order a Mesh for Cabinet Back Cover (part number MM607749X). Platform Item Description Part Number AG606666A InMode II White Back Cover door with Dust filter AS607830X AG606991A Optimas AG606992A Triton Black back Cover door with Dust Filter AS607831X

Section13: Troubleshooting 83 of 96 Section13: Troubleshooting The InMode System provides monitoring of all critical parameters to ensure safety of patient and user. If any of the following faults are detected system automatically goes to Stand By mode. Description of Faults with All Handpieces 11.1 Problem Description and Checks The System did not turn on Check the Power Cord connection.  Check that the Main Switch on Rear Panel is On.  Check that the On/Off Switch on Front Panel is On.   Check that the Emergency Button has not been pressed. Check the fuses on the Back Panel of the System.  Call Technical Service if the problem persists.  The System shuts down by itself Check the Power Cord connection.  Check the fuses on the Back Panel of the System.   Check that the Emergency Button has not been pressed. Call Technical Service if the problem persists.  Checksum  The software was not loaded properly from the Software Plug. Check the Plug connection and reboot the System.  Call Technical Service if the problem persists.  Fault H8002 - Handpiece is not connected Check the Handpiece connection.  Replace the Handpiece.  Call Technical Service if the problem persists.  Fault H8005, H800F, H8010 – System Memory Fault Call Technical Service if the problem persists. Fault H8601 – Distributor Card Connection Fault Call Technical Service if the problem persists. Fault H8609 – Water Temperature Fault Call Technical Service if the problem persists.

Section13: Troubleshooting 84 of 96 Problem Description and Checks Fault H800E- System Incompatible Software Version Call Technical Service if the problem persists. Fault H800F- System Memory Fault Call Technical Service if the problem persists. Fault H8010- System Memory Fault Call Technical Service if the problem persists. Faults H83XX, H84XX, H82XX Call Technical Service if the problem persists. Faults H86XX Water Flow Fault Call Technical Service if the problem persists. Faults H8003, H8006, H8007 - RF Related Faults Call Technical Service if the problem persists. Faults H8401, H8410, H8420, H8421, H8422, H8430, H8431, H8481 - IPL Related Faults Call Technical Service if the problem persists. Faults H8202, H8210, H8211, H8220-H8229, H8222 - Laser Related Faults Call Technical Service if the problem persists.

Section 14: System Specifications 85 of 96 Section 14: System Specifications Input Power Main Line Frequency (nominal 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) 12A Operating Parameters Ambient Temperature Range 15 – 30°C [59 – 86°F] Relative Humidity 30% to 80%, non-condensing Atmospheric Pressure 90 - 110kPa Warm-up Time If transported or stored at temperatures outside the operating temperature range, allow one hour for the device to reach room temperature before use. Transport and Storage Ambient Temperature Range -20 – 65oC [-4 – 14°F] Relative Humidity 0% to 80%, non-condensing Atmospheric Pressure 50 to 110kPa Dimensions System 46cm W x 46cm D x 100cm H [18.2’’ W x 18.2’’ D x 40’’ H] Handpiece Cable 170; 280cm L [67; 110`` L] Weight System 32.000 kg [70.548 lb] Diolaze Applicator 0.500 kg [1.100 lb] DiolazeXL Applicator 0.450 kg [0.925 lb] Lumecca Applicator 0.575 kg [1.268 lb] Fractora Applicator 0.100 kg [0.220 lb] Forma Applicator 0.110 kg [0.243 lb] Plus Applicator 0.170 kg [0.375 lb] BodyFX Applicator 0.900 kg [1.984 lb]

Section 14: System Specifications 86 of 96 MiniFX Applicator 0.750kg [1.653 lb] Diolaze Output Parameters Wavelength 81010 nm Fluence Variable, maintaining highest peak power Short 10 – 40 J/cm² Long 15 – 60 J/cm² Pulse width (duration) Short/Long Light guide cooling Strong: 2ºC Normal 10ºC, Weak 15ºC Spot size 8 mm x 50 mm Repetition Rate Long 0.8 Hz Short 0.8-1 Hz DiolazeXL Output Parameters Wavelength Fluence 5` – 40 J/cm² Pulse width (duration) Short/Long Light guide cooling Strong: 7ºC, Normal: 12ºC Spot size 11 mm x 27.5 mm Lumecca Output Parameters Wavelength 515 – 1200nm (SR 515) 580 – 1200nm (SR 580) Fluence 5 – 30J/cm² Pulse width (duration) Short/Long Light guide cooling Strong - 15ºC, Normal - 22ºC Spot size 10mm x 30mm Repetition Rate 1Hz

Section 14: System Specifications 87 of 96 Fractora Output Parameters RF Energy 5 – 62 energy levels Frequency Forma Output Parameters RF Energy 20 – 62 energy levels Frequency 1MHz Plus Output Parameters RF Energy 20 – 62 energy levels Frequency 1MHz BodyFX Output Parameters RF Power 10 – 50W Frequency 1MHz Vacuum Automatically controlled MiniFX Output Parameters RF Power 10 –25W Frequency 1MHz Vacuum Automatically controlled Output Power Curves 11.1 The curves that follow depict the changes for each RF mode at specific power settings.

Section 14: System Specifications 88 of 96 -1: Fractora 24 Pin Output Power versus Impedance14Figure -2: Fractora 60 Pin Output Power versus Impedance14Figure -3: Forma Output Power versus Impedance14Figure

Section 14: System Specifications 89 of 96 -4: Plus Output Power versus Impedance14Figure -5: BodyFX Output Power versus Impedance14Figure -6: MiniFX Output Power versus Impedance14Figure

Section 14: System Specifications 90 of 96 EMC Safety 11.1 The device has been tested and found to comply with the limits for the medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical clinical installation. This device generates uses and can radiate radio frequency energy. If not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that the interference to other devices, which can be determined by turning the device off and on, is caused by this instrument. The user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving device.  Increase the separation between the devices.   Connect the device into an outlet on a circuit different from that which was previously used. Consult InMode service personnel for help.  Interference to the device may be caused by portable and mobile RF communication equipment. In case of an interruption, beware of such a device in the vicinity.  Use of the System with any accessory, transducer or cable other than those specified may result in increased EMISSIONS or decreased IMMUNITY than those specified.  The System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the System should be observed to verify normal operation in the configuration in which it will be used.

Section 14: System Specifications 91 of 96 Guidance and manufacturer’s declaration – electromagnetic emissions The InMode System is intended for use in the electromagnetic environment specified below. The customer or the user of the Optimas should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A The System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Complies Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies

Section 14: System Specifications 92 of 96 Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input/output lines ± 2 kV for power supply lines Surge IEC 61000-4-4 ± 1 kV differential mode ± 2 kV common mode ± 1 kV differential mode ± 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 UT (>95 % dip <5 % in UT) for 0,5 cycle UT (60 % dip 40 % in UT) for 5 cycles UT (30 % dip 70 % in UT) for 25 cycles UT (>95 % dip <5 % in UT) for 5sec >95 % dip for 10 ms 60 % dip for 100 ms 30 % dip for 500 ms 95 % dip for 5000 ms Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE - UT is the AC mains voltage prior to application of the test level.

Section 14: System Specifications 93 of 96 Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. IMMUNITY Test IEC 60601 Test Level Compliance Level Electromagnetic environment – guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz [3] V [3] V/m Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 𝑑 = [3,5 𝑉1 ] √𝑃 = [3,5 3 ] √65 = 𝟖���. 𝟒 [𝒎] 80 𝑀𝐺���𝑧 𝑡𝑜 800 𝑀𝐺���𝑧 𝑑 = [ 7 𝐸1 ] √𝑃 = [7 3] √65 = 𝟏𝟖. 𝟖𝟏 [𝒎] 80 𝑀𝐺���𝑧 𝑡𝑜 2,5 𝐺𝐺���𝑧 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an a should be electromagnetic site survey, less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Section 14: System Specifications 94 of 96 a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above, the System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the System The System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter [W] Separation distance according to frequency of transmitter [m] 150 kHz to 80 MHz 𝑑 = [3,5 𝑉1 ] √𝑃 80 MHz to 800 MHz 𝑑 = [3,5 𝐸1 ] √𝑃 800 MHz to 2,5 GHz 𝑑 = [ 7 𝐸1 ] √𝑃 0,01 0.117 0.117 0.233 0,1 0.369 0.369 0.738 1 1.167 1.167 2.333 10 3.689 3.689 7.379 100 11.667 11.667 23.333 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Table from IEC60601-1-2, / 5.2.2.1 C & F 95 of 96 Table from IEC60601-1-2, / 5.2.2.1 C & F