# K170758: Thermage FLX System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Solta Medical
- Decided: Sep 22, 2017 after 193 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 118 ancestors in all.
13 later devices descend from it; 8 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090580: Thermage Thermacool NXT System and Accessories, Solta Medical, Inc. (2009) Summary page 4.
- K132431: Thermage CPT System, Solta Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K230663: Density (2023), 2 descendants of its own
- K221989: The Oligio (2022), 2 descendants of its own
- K240248: Volnewmer™ (2024), 1 descendant of its own
- K240313: Oligio X (2024), 1 descendant of its own
- K253504: Volnewmer™ (2026), 0 descendants of its own

## Indications for 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).

Source page: https://510kreport.com/device/K170758
Methodology: https://510kreport.com/methodology