# K040135: Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jun 21, 2004 after 151 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: 10 generations back to K943450 (1995). 25 ancestors in all.
496 later devices descend from it; 6 cite it directly.
0 of 522 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021402: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.

## Most influential descendants
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K060448: Lumenis One Family of Systems; Lumenis One. (2006), 297 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K070004: Accent (2007), 181 descendants of its own

## Indications for use
The Thermage ThermaCool System is indicated for use in: Dermatologic and general surgical procedures for electro coagulation and hemostasis, Non-invasive treatment of periorbital wrinkles and rhytids Non-invasive treatment of facial wrinkles and rhytids

Source page: https://510kreport.com/device/K040135
Methodology: https://510kreport.com/methodology