Thermage FLX System and Accessories

K170758 · Solta Medical · GEI · Sep 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170758
• Device Name: Thermage FLX System and Accessories
• Applicant: Solta Medical
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The radiofrequency-energy only 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 radio frequency energy and skin vibration by the Thermage FLX System is 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; · Temporary improvement of local circulation (i.e., blood circulation).

Device Story

Thermage FLX System delivers radiofrequency (RF) energy to tissue for selective coagulation while conductively cooling epidermis. System comprises console, handpiece, and disposable treatment tip; accessories include return pad, skin marking grid, coupling media, cryogen, and optional footswitch. Device monitors skin contact during treatment; employs RF tuning to deliver energy across varying tissue impedances via single or multiple pass stamping motions. Operated by clinicians in professional settings. System provides RF-only or simultaneous RF and skin vibration modes. Output affects tissue via thermal coagulation; benefits include wrinkle reduction, cellulite appearance improvement, and relief of muscle-related symptoms. User interacts via LCD touchscreen.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electrical safety, electromagnetic compatibility, usability engineering (IEC 62366-1), and biocompatibility evaluation per ISO 10993-1. Functional, simulated use, environmental, and transport testing performed on representative units.

Technological Characteristics

RF electrosurgical system; 6.78 MHz frequency; 400W max average power. Components: console, handpiece, disposable tip. Features: conductive epidermal cooling, RF impedance tuning, skin vibration. User interface: LCD touchscreen. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-2 (HF surgical equipment), ISO 10993-1 (biocompatibility). Software lifecycle per EN ISO 62304.

Indications for Use

Indicated for dermatologic/general surgical electrocoagulation and hemostasis; non-invasive treatment of periorbital/general wrinkles and rhytids; temporary improvement of cellulite appearance; relief of minor muscle aches, pains, and spasms; and temporary improvement of local blood circulation.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Thermage ThermaCool CPT (K090580)
• Thermage ThermaCool CPT (K132431)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

September 22, 2017

Solta Medical. Inc. % Ms. Melissa Thomas Sr. Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609

Re: K170758

Trade/Device Name: Thermage FLX System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, ISA Dated: August 28, 2017 Received: August 30, 2017

Dear Ms. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170758

Device Name Thermage FLX System

#### Indications for Use (Describe)

- The radiofrequency-energy only 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 radio frequency energy and skin vibration by the Thermage FLX System is 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;
- · Temporary improvement of local circulation (i.e., blood circulation).

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <table><tr><td><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) </td><td><input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </td></tr></table> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) |
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### 1 510(k) SUMMARY

### 1. General Information

| Submitter: | Contact Person: |
|--------------------------------------|---------------------------|
| Solta Medical Inc. | Melissa Thomas |
| 11720 North Creek Pkwy N., Suite 100 | 1400 North Goodman Street |
| Bothell, WA 98011 | Rochester, NY 14609 |
| USA | 585-338-6045 |
| General Telephone: [phone] | [e-mail] |

Preparation Date:

February 23, 2017

- 2. Names
Device Name Thermage FLX System Classification Name Electrosurgical Cutting and Coagulation Device and Accessories Electrosurgical Unit and Accessories Common Name: CFR References: 21 CFR 878.4400 Product Codes: GEX, ISA No performance standards for this device have been promulgated Performance Standards: under Section 514, Federal Food, Drug and Cosmetics Act.

# 3. Predicate Devices

Thermage ThermaCool CPT cleared under K090580 on June 26, 2009 Thermage ThermaCool CPT cleared under K132431 on September 6, 2013

# 4. Product Description

The subject of this 510(k) submission is for the Thermage FLX System which is substantially equivalent to the predicate Thermage CPT. The Thermage FLX System is based on the technology and the performance of the existing Thermage CPT System and includes a similar RF (RF) Generator and Accessories.

The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage FLX System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.

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The Thermage FLX System is comprised of three sub-systems: (1) the Console, (2) Handpiece and (3) Treatment Tip. Accessories used during each individual treatment included the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch.

# 5. Indications for Use

The radiofrequency (RF) 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 is 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;
- . Temporary improvement of local circulation (i.e., blood circulation).

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- 6. Summary of Technological Characteristics
The technological characteristics of the Thermage FLX System are substantially equivalent to those of the predicate devices.

| Characteristic | Subject Device<br>Thermage FLX System | K090580 and<br>K132431 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended Use | Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis, non-invasive treatment<br>of periorbital wrinkles and rhytids. | Identical as<br>subject device |
| Indications for<br>Use | The radiofrequency-energy only delivery components of the<br>Thermage FLX System are indicated for use in:<br>Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis;Non-invasive treatment of periorbital wrinkles and<br>rhytids including upper and lower eyelids;Non-invasive treatment of wrinkles and rhytids.The simultaneous application of radio frequency energy and<br>skin vibration by the Thermage FLX System is indicated for<br>use in:<br>Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis;Non-invasive treatment of periorbital wrinkles and<br>rhytids;Non-invasive treatment of wrinkles and rhytids;Temporary improvement in the appearance of<br>cellulite;Relief of minor muscle aches and pains;Relief of muscle spasms;Temporary improvement of local circulation (i.e.,<br>blood circulation). | Identical as<br>subject device |
| Maximum<br>Average Power | 400W | Identical as<br>subject device |
| User interface | LCD / Touchscreen Technology for user interaction and<br>controls | LCD Screen |
| Mode of<br>Operation | Manual or Footswitch | Identical as<br>subject device |
| Frequency | 6.78 MHz | Identical as<br>subject device |

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- 7. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Thermage FLX System is substantially equivalent to the predicate devices.

### 8. Brief Summary of Nonclinical Tests and Results

Safety tests of the Thermage FLX System have demonstrated its compliance with applicable requirements of the following electrical standards:

| IEC 60601-1:2005 + C1(2006) +<br>C2(2007) + AM1(2012) or IEC<br>60601-1:2012-Ed. 3.1 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 ed3.0 (2007)/AC:<br>2010 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Electromagnetic compatibility -<br>Requirements and tests |
| IEC 60601-1-6:2010+A1:2013 | Medical electrical equipment. Part 1-6: General<br>requirements for basic safety and essential performance.<br>Collateral standard. Usability |
| IEC 60601-2-2:2009+C1:2014 | Medical electrical equipment - Part 2-2: Particular<br>requirements for the basic safety and essential<br>performance of high frequency surgical equipment and<br>high frequency surgical accessories |
| IEC 62366-1:2015 | Medical devices-Application of usability engineering<br>to medical devices |

Functional, simulated use, environmental and transport testing were also performed on representative units.

Software was verified and validated in accordance with the Solta Medical software quality procedures which comply with EN ISO 62304:2006/AC:2008 Medical device software --Software life cycle processes.

Electromagnetic Compatibility: The console was tested to by a third party and was found to comply.

Electrical Safety: The laser console was tested to by a third party and was found to comply.

Biocompatibility: The biocompatibility evaluation of patient contacting materials was conducted per FDA draft guidance document, "Use of International Standard ISO 10993-1,

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"Biological Evaluation of medical devices Part 1: Evaluation and Testing within a risk management process" dated June 16, 2016.

The Thermage FLX System passed all of the above applicable standards testing. This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate devices.

- 9. Conclusion
The Thermage FLX System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to, the predicate devices. Non-clinical test results demonstrate that the Thermage FLX System is substantially equivalent to the predicate devices and no new issues of safety or effectiveness have been raised.