# K173759: Thermage CPT System and Accessories

- Pathway: 510(k) (Special)
- Applicant: Solta Medical
- Decided: Jan 8, 2018 after 28 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 121 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
- K242241: Sunny (2025), 0 descendants of its own
- K233118: DUET-V (Model: ESK-3261DV) (2025), 0 descendants of its own

## Recalls of this device
- Feb 16, 2023 · Class II · Z-1354-2023: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

## Indications for use
The radiofrequency energy delivery components of the Thermage CPT System and Accessories 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 CPT System and Accessories 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; • Temporary improvement of local circulation (i.e., blood circulation).

Source page: https://510kreport.com/device/K173759
Methodology: https://510kreport.com/methodology