Thermage FLX TG-3A User Manual Rev A

Thermage FLX System User Manual

Introduction

Copyright This manual may not be copied, translated, or reproduced in whole or in part without the express written consent of Solta Medical (henceforth “Solta”). © 2018 Solta Medical, Inc. All rights reserved.

Trademarks ®/TM are trademarks of Solta Medical, Inc. or its affiliates in the United States and other countries. All other product or brand names and logos are trademarks of their respective owners.

Patents US patents and pending patent applications apply to this product. For details, visit http://www.thermage.com/patents

Rx Only CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a licensed health care professional only.

Authorized Representative MDSS GmbH Schiffgraben 41 30175 Hannover Germany Phone: +49 511-6262 8630 FAX: +49 511-6262 8633 www.mdss.com

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 2 of 85

Thermage FLX System User Manual

Introduction

TABLE OF CONTENTS 1

INTRODUCTION...6 1.1

About This Manual... 6

1.2

Conventions Used in This Manual... 6

1.3 Intended Use, Indications and Contraindications... 8 Intended Use/Indications... 8 Contraindications... 8 1.4 Important Patient Safety Information... 9 1.5 Patient Types not Studied... 10 1.6 Equipment Safety... 11

2 3 4 5

THERMAGE FLX SYSTEM OVERVIEW...13 SYSTEM CONTROLS...15 HANDPIECE CONTROLS...18 TREATMENT TIPS...19 5.1 Eye Tip 0.25cm2 – for Treatment Over Eye... 19 5.2 Total Tips – 3.0cm2 or 4.0cm2 – for Treatment of Face and Off-Face Body Areas... 20 5.3 Body Tip 16.0cm2 – for Off-Face Body Treatment... 20

6

ACCESSORIES...21 Return Pad... 21 Cryogen Canister... 21 Coupling Fluid... 22 Skin Marking Paper... 23 Footswitch (Optional)... 23

7

SYSTEM STATUS MODES...24 7.1

Action Required... 24

7.2

Adjust Level... 25

7.3 Ready. ... 26 7.4

Armed... 27

7.5

Active... 27

7.6 REP Complete... 29

8

GETTING STARTED...30 8.1 Installation... 30 8.2 Training... 30 8.3 Setting Up the System... 30 Inspect System for Damage... 30 Positioning the System... 30 Connecting the AC Power Cord... 31 Connecting the Footswitch (Optional)... 31 Cryogen Canister Installation... 31 Powering on the System... 33

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 3 of 85

Thermage FLX System User Manual

Introduction

Connecting the Handpiece... 33 Adjusting Volume... 35 USB Port... 35 8.4

Configuring the System... 36 Power Off/Restart the System... 38

9

TREATING A PATIENT...39 9.1 Pre-Treatment Preparation... 39 9.2 System Preparation. ... 43 9.3 Treatment Setup... 45 9.4 Treatment Procedure. ... 48 Examine the Treatment Tip... 48 Apply Coupling Fluid... 49 Deliver Treatment... 49 Change Treatment Level Setting... 51 Change Vibration Level Settings... 52 During Treatment... 53 Treatment Guidelines... 53 Treatment Completion... 55

10 CLEANING...56 Treatment TIp... 56 Handpiece... 56 Console... 56 Touchscreen... 57 Footswitch... 57

11 TROUBLESHOOTING...58 12 ERROR CODES...59 13 MAINTENANCE, TRANSPORTATION AND WARRANTY...64 13.1 Maintenance... 64 Routine Maintenance... 64 Disposal of System and Accessories... 64 13.2 Transportation. ... 64 13.3 Limited Warranty... 65

14 CONTACT INFORMATION ...66 Product Complaint and Technical Support Contact Information (Including Product Related Complaints):... 66 Customer Service and Ordering Contact Information:... 66

15 TECHNICAL INFORMATION...67 15.1 Electrical Specifications... 67 AC Input Rating... 67 RF Output... 67 Electrical Safety... 68

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 4 of 85

Thermage FLX System User Manual

Introduction

Connection to the Analog and Digital Interfaces, such as Ethernet Port... 75 Power Output Restrictions... 75 Settings Levels... 75 Measurement Accuracy... 75 15.2 Enclosure Material... 75 Footswitch Specifications... 75 15.3 Mechanical Specifications – System... 76 15.4 Environmental Conditions... 76 Operational Conditions... 76 Storage and Transportation Conditions... 76

16 ENERGY OUTPUT TABLES ...77 17 HISTORICAL EYELID CLINICAL DATA...78 18 LABELING SYMBOLS...79

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 5 of 85

Thermage FLX System User Manual

1

Introduction

INTRODUCTION

Read the information in the User Manual in its entirety before using the Thermage FLX™ System, accessories, components, and performing the Thermage® procedure. Please contact Solta Medical Customer Service or your local authorized distributor of Solta Medical products if you have any questions.

1.1 ABOUT THIS MANUAL This manual is a reference for the Thermage FLX System. It is intended to be used by healthcare professionals with appropriate training. This manual includes a general overview of the System along with detailed instructions for using the System. This manual also supplies other information of importance to the user and is intended as a User Manual only.

1.2 CONVENTIONS USED IN THIS MANUAL The following list shows conventions that are used throughout this manual.

Warning Notice

August 2018 Copyright © 2018

Warnings consist of alert information necessary to prevent death, serious injury, or adverse effects to the patient or user. Notices consist of alert information necessary for the user to take action for proper use of the System, or to protect the System from malfunction or damage.

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 6 of 85

Thermage FLX System User Manual

Introduction

THE THERMAGE FLX SYSTEM

Touchscreen Display Power Button

Handpiece

Treatment Tip

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 7 of 85

Thermage FLX System User Manual

Introduction

1.3 INTENDED USE, INDICATIONS AND CONTRAINDICATIONS INTENDED USE/INDICATIONS Region USA

Indication for Use The radiofrequency energy delivery components of the Thermage FLX System are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; • Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage FLX System are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids; • Non-invasive treatment of wrinkles and rhytids; • Temporary improvement in the appearance of cellulite; • Relief of minor muscle aches and pains; • Relief of muscle spasms;

CE Compliant

• Temporary improvement of local circulation (i.e., blood circulation). The radiofrequency (RF) energy delivery components of the Thermage FLX System and Accessories are indicated for use in: • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; • Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage FLX System and Accessories are indicated for use in: • Non-invasive treatment of periorbital wrinkles and rhytids • Non-invasive treatment of wrinkles and rhytids

CONTRAINDICATIONS For all regions, the Thermage System is contraindicated for use in patients with an implantable pacemaker, an Automatic Implantable Cardioverter/Defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency (RF) field or current. August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 8 of 85

Thermage FLX System User Manual

Introduction

1.4 IMPORTANT PATIENT SAFETY INFORMATION For treatment over the eye (upper and lower eyelid, or within the periorbital rim), ensure the use of plastic ocular shields. Do not use metal eye shields.

Before using the Thermage FLX System, read the safety considerations outlined in this manual. The Thermage FLX System must be used by health care professionals who have adequate training in the use of the device. Earlier generations of the Thermage System (e.g. ThermaCool, NXT, CPT) have been studied in US clinical trials for the treatment of wrinkles and rhytids. Use of the System for indications other than those expressed in this manual are considered “off-label”. The side effects associated with treating “off-label” have not been evaluated in clinical studies. “Off-label” treatment may result in a different safety profile. Professional discretion by the health care professional is necessary when treating body areas in proximity to major nerve bundles otherwise it may result nerve damage. Be aware that there are potential risks resulting from neuromuscular stimulation when using the System. Caution should be used when treating skin directly over metal dental work. In particular, when treating over metal dental work of large surface areas (such as crowns, braces, implants, etc.) consideration should be given to inserting dry absorbent cotton roll(s) between the dental work and the inner cheek area to prevent radiofrequency heating of the metal materials. Such heating may result in burns to the skin, dental pain, and/or damage to the dental work. Most frequently reported side effects during a Thermage FLX treatment are mild to moderate pain. Typically, the discomfort is temporary during the procedure and localized within the treatment area. Rarely, patients have reported transient aching in the treatment area lasting up to several months. The most frequently reported side effects after a Thermage treatment are: • Burns - The procedure produces heating in the upper layers of the skin, and may cause burns and subsequent blister and scab formation. There is a small chance of scar formation. Application of topical steroidal or antibiotic preparations may be of benefit. In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device. • Surface Irregularities - Variously described as (localized) “small dents in the surface of the skin,” “rippling,” “ridging,” “waffle patterns”, or “fat loss” (covering a larger surface area). Frequently, surface irregularities are not evident immediately post-treatment, but show up later (1 or more months post-treatment). In most cases Solta recommends that surface irregularities be monitored for a period of six months post onset. Tissue fillers may be considered as a treatment option if the condition does not resolve on its own. August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 9 of 85

Thermage FLX System User Manual

Introduction

• Altered sensations - Described as “numbness”, “tingling” or “temporary paralysis”. Altered sensation typically resolves in a short period of time, but infrequently may persist up to several weeks. This adverse event is rare and, as is the case with an invasive face-lift procedure, resolves over time without intervention. • Lumps or Nodules - Sub-cutaneous nodules occurring primarily in the neck area may occur. It typically self-resolves within 1 or 2 weeks without adverse sequelae. • Hyperpigmentation - Usually resolve over the course of time (within several months). • Bruising - May occur in rare cases and typically dissipates within several days. Bruising may be more typically associated with the use of some injected anesthetic agents (e.g. nerve blocks). • Erythema - May occur in mild form and typically resolve within a few hours. However, on rare occasions, erythema has been reported to last longer (up to several weeks). Blanching usually resolves within twenty-four (24) hours. • Swelling - May occur and typically resolves within 5 days, but can persist up to several weeks. Application of cold compresses or gels immediately following the treatment may help to reduce the occurrence of this event. • Itching - There have been occasional reports of a mild to moderate, transient itching sensation in the treatment area. Application of over-the-counter topical preparations may be helpful in relieving the symptoms. • Herpes simplex - May result in rare cases in a treated area that has previously been infected with the virus. Reactivation of HSV is generally thought to occur most commonly in the perioral and genital skin areas after various stimuli.

1.5 PATIENT TYPES NOT STUDIED For all regions, the Thermage System is contraindicated for use in patients with an implantable pacemaker, an Automatic Implantable Cardioverter/Defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency (RF) field or current. The ideal treatment age is from 35-60 years old. However, Solta Medical has not studied the following patient types. Use of the Thermage FLX System with pregnant and/or breast feeding women, children, people with diabetes, auto-immune disease (e.g. Lupus), herpes simplex, or epilepsy has not been studied. Use of the Thermage FLX System with patients with permanent make-up and/or tattoos has not been studied. Use of the Thermage FLX System over dermal fillers has not been studied.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 10 of 85

Thermage FLX System User Manual

Introduction

1.6 EQUIPMENT SAFETY The safe and effective use of Thermage system is highly dependent upon factors under the control of the user. It is important that all warnings, notices, and the supplied user manual be read, understood and followed before proceeding with treatment. For maximum safety, observe the following warnings and notices. To avoid risk of electrical shock or injury: Do not use this System in the presence of flammable anesthetics, other flammable gases, near flammable fluids (e.g. skin preparation agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire precautions at all times. Allow flammable agents used for cleaning, disinfecting, or as solvents to evaporate completely before use of the equipment or application of RF energy. Do not use the System near critical life-support equipment. Radiofrequency electromagnetic emissions can interfere with the operation of electronic equipment. Place all monitoring electrodes, such as for an electrocardiogram (ECG, EKG), as far as possible from the treatment area when the System and physiological monitoring equipment are used simultaneously on the patient. The use of monitoring systems incorporating high frequency current-limiting devices is recommended. Do not use this device in oxygen-enriched atmosphere or in the presence of nitrous oxide (N2O). Interference produced by the System may adversely influence the operation of other electronic equipment. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 11 of 85

Thermage FLX System User Manual

Introduction

The use of accessories, transducers and cables other than those specified could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Thermage FLX System and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Thermage FLX System, including cables specified by Solta. Otherwise, degradation of the performance of this equipment could result. Be aware that failure of the System could result in an unintended increase in output power. This equipment must only be connected to a supply mains with protective earth (i.e. grounded outlet). Extension cords and/or adapter plugs must not be used. Do not modify or attempt to service the equipment (e.g. System and accessories). Use only Solta-supplied components and accessories: -

System console, power cord, handpiece, and treatment tips

-

Return pad, cryogen, coupling fluid, and skin marking paper

All Solta-supplied components and accessories should be inspected regularly for any signs of damage prior to use.

The Thermage FLX System is intended to be used in a Professional healthcare facility environment (e.g.; doctor’s offices, clinics, surgery room, intensive care, and patient rooms). It does not include areas where there are sources of intense electromagnetic disturbances, such as a RF shielded room of magnetic resonance imaging, or in operating rooms near active HF surgical equipment. It is essential the Thermage FLX System not deliver an excessive amount of energy to the patient per the selected treatment setting. Placing the system in areas where intense electromagnetic disturbances could be present may result in excessive energy delivered to the patient, or unexpected changes in treatment levels that could lead to possible burns to the patient. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 12 of 85

Thermage FLX System User Manual

2

Thermage FLX System Overview

THERMAGE FLX SYSTEM OVERVIEW

The Thermage FLX System (‘System’) is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures. The System consists of the following components: Console, including touchscreen, a Handpiece, Treatment Tip(s), AC power cord and an optional footswitch. The System is used with the following Solta-supplied accessories: cryogen canister, return pad, coupling fluid and skin marking paper. Only Solta-supplied components and accessories should be used with the System to avoid unsafe use or product malfunction. Listing of all major System components and accessories, along with their respective model numbers are as follows: Thermage FLX System Components and Accessories Description

Model #

Console, including Touchscreen

TG-3A

Handpiece

TH-6 series

Treatment Tip(s) (Non-sterile)

TT series

Footswitch (optional)

TW series

Cryogen canister

TC-2 series

Return pad

TR-4 series

Coupling fluid

TF series

Skin marking paper

SM series

The System continuously monitors output power, output energy, treatment duration, and measured impedance. The System also controls the coolant delivery through the Handpiece. The Handpiece delivers RF energy while cooling tissue by thermal conduction.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 13 of 85

Thermage FLX System User Manual

Thermage FLX System Overview

Figure 1 Thermage FLX System Components and Accessories

Touchscreen

Console

Power Button

Handpiece Treatment Tip AC Power Inlet and Network Connection

Footswitch Inlet

Footswitch

Component Name

Function

Console

Houses all electro-mechanical components for system operation including generation of RF energy

Touchscreen

Interactive controls for system operation

Power Button

Turns system on and off. The power button illuminates when the system is connected to electrical outlet

Handpiece

Primary option to activate treatment; location for treatment tip

Treatment Tip

Electrode containing the primary treatment parameters; determines treatment site size

AC Power Inlet and Network Connection

To connect system power cord and internet network cable

Footswitch Inlet

To connect footswitch to the system

Footswitch

Secondary option to activate treatment

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 14 of 85

Thermage FLX System User Manual

3

System Controls

SYSTEM CONTROLS

The System controls include the power button, Touchscreen, Handpiece, and footswitch. Power Button Press The

button to power the system on and off. is illuminated when the system is connected to an electrical outlet.

the system will be powered on, the screen activates, and the system By pressing conducts a startup process verifying system functions. The system may take up to 5 minutes to complete the startup process. Touchscreen All system controls are accessed through the interactive touchscreen allowing the user to quickly navigate the menus, prepare for treatment, and make adjustments during a treatment. The layout of the touchscreen consists of the system status display bar, system tools button, energy delivered and REPs status, tip selection display, vibration control button, treatment level controls and continue button. Controls on the Touchscreen System Tool Button

System Status Bar

Energy Delivered Status

Tip Selection Display

REPs Status Treatment Level Indicator

Vibration Button and Indicator

Adjustment Buttons

August 2018 Copyright © 2018

Solta Medical, Inc.

Continue Button

Part Number: P009418-04 Revision A Page 15 of 85

Thermage FLX System User Manual

System Controls

Functions of the System Controls and Indicators Screen Function

Description

System Status Bar

The status bar at the top of each screen indicates the current System mode. The message on this bar is dependent upon the System mode; follow the instructions on the screen, if required.

System Tools Button

Press the System Tools button at any time to display the System Tools menu.

Energy Delivered Status

The number represents the total energy delivered (kJ) over the course of the treatment. % bar: represents the energy delivery progress during each REP. Avg: represents the average energy density (J/cm2) delivered per radiofrequency energy pulse (REP) over the course of the treatment.

REPs Status

REPs bar: presents the number of REPs completed with the attached Treatment Tip. ‘REP’ stands for Radiofrequency Energy Pulse, which means a single pulse transmission of the RF energy through a given electrode (Tip). Rem: represents the number of REPs remaining on the attached Treatment Tip.

Treatment Level Indicator

The number displays the selected treatment level. For each Treatment Tip size, there are pre-selected combinations of power, energy, current, time and cooling parameters that correspond to each level. Higher numbers correspond to increased power and energy. The percentage bar is a visual aid only and does not correlate to actual tissue temperature. Increase or decrease the treatment level with the Increment and Decrement buttons. Each press of the or increases or decreases the treatment level by 0.5. Press and hold on the buttons to continuously change the value.

Adjustment Buttons In general, the and buttons are used to increase or decrease the selected function respectively, depending on the System mode, such as treatment level or volume control. Continue Button

In general, the continue button is used to confirm a setting change or acknowledge a System message. The function of this button is dependent upon the System mode; follow the instructions on the screen.

Vibration Button and Indicator

The vibration button changes the vibration level when used with selected Treatment Tips. Tapping the vibration level button cycles the intensity between off (default), low, medium and high. The vibration level is identified to the left of the button. Vibration Indicator displays current vibration level selected.

Tip Selection display

August 2018 Copyright © 2018

The tip selection display indicates the Treatment Tip type currently attached to the Handpiece.

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 16 of 85

Thermage FLX System User Manual

System Controls

Footswitch The footswitch (also referred to as foot pedal) is an alternative method for activating treatment rather than using the handpiece for activation control. When connected to the system, the treatment activation control will default to the footswitch. Disconnect the footswitch from system when handpiece activation control is desired.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 17 of 85

Thermage FLX System User Manual

4

Handpiece Controls

HANDPIECE CONTROLS

The Handpiece is the primary option to activate treatment in the delivery of RF energy for selective coagulation of tissue while conductively cooling the epidermis. A treatment tip must be securely attached to the handpiece before use. The Handpiece is provided with the System. The Handpiece treatment controls allow the user to select treatment level and vibration level (off, low, medium, and high). Handpiece Activation Button

Handpiece Controls

Shown with a treatment tip attached Functions of the Control Buttons on the Handpiece Controls

Description

Handpiece Activation Press and hold the activation button to initiate the Active mode. Button Release the activation button to terminate the Active mode and interrupt RF delivery. Note: Treatment control activation will default to the footswitch when footswitch is connected to system. Handpiece Control Buttons

Treatment Control Buttons Increase or decrease the treatment level with the Increment and Decrement buttons. Each press of the or treatment level by 0.5.

increases or decreases the

Press and hold a button to continuously change the value. Vibration Button (

):

The vibration button changes the vibration level when used with selected Treatment Tips. Press the vibration level button to cycle the vibration between off (default), low, medium and high. Continue Button ( √ ) In general, the continue button is used to confirm a setting change or acknowledge a System message. The function of this button is dependent upon the System mode; follow the instructions on the screen. August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 18 of 85

Thermage FLX System User Manual

5

Treatment Tips

TREATMENT TIPS Solta-supplied Treatment Tips are for single patient use. Do not reuse or attempt to reprocess. Multiple patient use creates a risk of cross contamination of microorganisms from patient to another.

The Treatment Tips are single use accessories, available in various treatment site REP counts, and are designed for efficient treatment of small and large treatment areas. Treatment Tip sizes are available for treatment over the eye, treatment of the face, and treatment of off-face body areas such as abdomen, arms, thighs, buttocks, and knees. The System allows vibration mode to be active with all Treatment Tip sizes except for Treatment Tips dedicated for treating over the eye. The treatment tip type will be displayed on the touchscreen when attached to the handpiece. The treatment tip types provided on the Thermage FLX system consist of the following:

5.1 EYE TIP 0.25cm2 – FOR TREATMENT OVER EYE Ensure the use of plastic ocular eyeshields when treating over the eye (upper and lower eyelid), or within the periorbital rim. Do not use metal eye shields. Solta Medical recommends Oculoplastic® plastic globe protector to use. Refer to manufacturer’s instructions for proper placement and use of eye shields. Do not use of vibration when treating the face around the eye areas while plastic ocular shields are in use. Vibration may cause displacement of the ocular shields resulting in increased risk of corneal abrasions or ocular damage.

The eye tip (0.25cm2) is the smallest of the treatment tips provided and is used for treating over the eye (upper and lower eyelid), or within the periorbital rim. Vibration is not available when using any version of the eye tip.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 19 of 85

Thermage FLX System User Manual

Treatment Tips

5.2 TOTAL TIPS – 3.0cm2 OR 4.0cm2 – FOR TREATMENT OF FACE AND OFF-FACE BODY AREAS Total Tips come in different sizes (3.0cm2 and 4.0cm2) and are distinguishable by different colors. These tips are used for treatment of the face (excluding over the eye) as well as for smaller treatment areas of the abdomen, neck, arms, thighs, buttocks, and knees. Vibration is available for all versions of the Total Tips.

5.3 BODY TIP 16.0cm2 – FOR OFF-FACE BODY TREATMENT The Body Tip (16.0cm2) is the largest of the treatment tips provided and is used for treatment of larger treatment areas of the abdomen, arms, thighs, buttock, and knees. Vibration is available for all versions of the Body Tip.

August 2018 Copyright © 2018

Solta Medical, Inc.

Part Number: P009418-04 Revision A Page 20 of 85