# K031046: Thermacool TC System

- Pathway: 510(k) (Special)
- Applicant: Thermage, Inc.
- Decided: May 22, 2003 after 50 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.
22 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002)
- K021402: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.

## Most influential descendants
- K072849: Modification to Thermage Thermacool System (2008), 20 descendants of its own
- K090580: Thermage Thermacool NXT System and Accessories (2009), 19 descendants of its own
- K132431: Thermage CPT System (2013), 17 descendants of its own
- K170758: Thermage FLX System and Accessories (2017), 13 descendants of its own
- K230663: Density (2023), 2 descendants of its own

## Indications for use
The ThermaCool TC System is indicated for use in Non-invasive treatment of periorbital rhytids and wrinkles Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K031046
Methodology: https://510kreport.com/methodology