# K052936: Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jun 12, 2007 after 601 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: 13 generations back to K943450 (1995). 55 ancestors in all.
103 later devices descend from it; 2 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043402: Thermage Thermacool System, Thermage, Inc. (2005). Our reading of the summary gave K043042, FDA’s number for Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051… (Nobel Biocare AB). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ThermaCool System”.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.

## Most influential descendants
- K073572: Matrix RF Applicator (2008), 102 descendants of its own
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), 64 descendants of its own
- K130501: Intensif (2014), 57 descendants of its own
- K180189: InMode System with Fractora3D/3D-90 Applicators (2018), 38 descendants of its own
- K102461: Fractora (2011), 24 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 including the upper and lower eyelids • Non-invasive treatment of facial wrinkles and rhytids

Source page: https://510kreport.com/device/K052936
Methodology: https://510kreport.com/methodology