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 Description

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.

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.

AI/ML Overview

The provided document, a 510(k) summary for the Thermage FLX System, describes the device, its intended use, and a comparison to predicate devices, but does not contain information about specific acceptance criteria, a clinical study proving the device meets those criteria, or the details typically associated with clinical trial reporting (sample size, data provenance, expert adjudication, MRMC studies, ground truth establishment, or training set details).

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with electrical and safety standards.

Therefore, the requested information based solely on the provided text is largely unavailable.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that the device passes various electrical and safety standards, but it doesn't present specific performance metrics or acceptance criteria for clinical effectiveness (e.g., wrinkle reduction percentage, cellulite improvement rate, etc.) that would typically be associated with an "acceptance criteria" table for device performance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document details non-clinical tests (electrical safety, EMC, software, biocompatibility) but does not mention any clinical test set, subjects, or data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. As no clinical test set is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This information is not provided. The document does not mention any MRMC studies or human reader improvement with or without AI assistance, as the device itself is not described as an AI or diagnostic tool requiring such studies. It's an energy-based therapeutic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not provided. This question is not applicable as the device is not an algorithm acting in a standalone capacity; it's a physical medical device.

7. The Type of Ground Truth Used

This information is not provided as no clinical study or test set requiring ground truth is described. For the non-clinical tests, compliance with specified standards (e.g., IEC 60601-1) serves as the "ground truth" for safety and electrical performance.

8. The Sample Size for the Training Set

This information is not provided. The device is an energy-based system, not an AI or machine learning algorithm, so the concept of a "training set" in this context is not applicable.

9. How the Ground Truth for the Training Set was Established

This information is not provided, as there is no training set mentioned.

Summary based on the document:

The Thermage FLX System's "study" in this 510(k) context primarily refers to non-clinical testing to demonstrate compliance with relevant electrical, safety, and software standards, as well as functional, simulated use, environmental, and transport testing. The acceptance criteria for these tests are typically defined by the requirements of the standards themselves (e.g., passing specific electrical safety limits, meeting EMC requirements). The document asserts that the device passed all applicable standards testing, thereby demonstrating its safety and functional equivalence to predicate devices. It relies on a demonstration of substantial equivalence to previously cleared devices (Thermage ThermaCool CPT cleared under K090580 and K132431) rather than a de novo clinical trial with specific clinical performance acceptance criteria.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C)	Prescription Use (Part 21 CFR 201 Subpart D)	Over-The-Counter Use (21 CFR 201 Subpart C)
Prescription Use (Part 21 CFR 201 Subpart D)	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)

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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: 510-259-5299	Melissa.Thomas@bausch.com

Preparation Date:

February 23, 2017

1. 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.

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

Characteristic	Subject DeviceThermage FLX System	K090580 andK132431
Intended Use	Dermatologic and general surgical procedures forelectrocoagulation and hemostasis, non-invasive treatmentof periorbital wrinkles and rhytids.	Identical assubject device
Indications forUse	The radiofrequency-energy only delivery components of theThermage FLX System are indicated for use in:Dermatologic and general surgical procedures forelectrocoagulation and hemostasis;Non-invasive treatment of periorbital wrinkles andrhytids including upper and lower eyelids;Non-invasive treatment of wrinkles and rhytids.The simultaneous application of radio frequency energy andskin vibration by the Thermage FLX System is indicated foruse in:Dermatologic and general surgical procedures forelectrocoagulation and hemostasis;Non-invasive treatment of periorbital wrinkles andrhytids;Non-invasive treatment of wrinkles and rhytids;Temporary improvement in the appearance ofcellulite;Relief of minor muscle aches and pains;Relief of muscle spasms;Temporary improvement of local circulation (i.e.,blood circulation).	Identical assubject device
MaximumAverage Power	400W	Identical assubject device
User interface	LCD / Touchscreen Technology for user interaction andcontrols	LCD Screen
Mode ofOperation	Manual or Footswitch	Identical assubject device
Frequency	6.78 MHz	Identical assubject device

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1. 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) +C2(2007) + AM1(2012) or IEC60601-1:2012-Ed. 3.1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-1-2 ed3.0 (2007)/AC:2010	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-1-6:2010+A1:2013	Medical electrical equipment. Part 1-6: Generalrequirements for basic safety and essential performance.Collateral standard. Usability
IEC 60601-2-2:2009+C1:2014	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipment andhigh frequency surgical accessories
IEC 62366-1:2015	Medical devices-Application of usability engineeringto 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.

1. 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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.