# K030142: Thermacool TC System

- Pathway: 510(k) (Special)
- Applicant: Thermage, Inc.
- Decided: Feb 3, 2003 after 19 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.
773 later devices descend from it; 3 cite it directly.
0 of 799 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
- K031671: Polaris WR (2003), 678 descendants of its own
- K033942: Thermage Thermacool System (2004), 527 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K041959: Polaris DS/Comet (2004), 301 descendants of its own
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 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/K030142
Methodology: https://510kreport.com/methodology