# K013639: Thermage Thermacool TC System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jan 29, 2002 after 85 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: 8 generations back to K943450 (1995). 23 ancestors in all.
799 later devices descend from it; 11 cite it directly.
0 of 823 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013034: Modification to: Thermacool Iia, Thermage, Inc. (2001) Summary page 1.
- K003183: Thermage Thermacool II System, Thermage, Inc. (2000) Summary page 1.
- K000944: Thermage Thermacool System, Thermage, Inc. (2000) Summary page 1.
- K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M, Nikomed U.S.A., Inc. (2000) Summary page 1.
- K933804: Lectron II Conductive Gel/Cadwell Electrode Gel, Cadwell Laboratories, Inc. (1994) Summary page 1.

## Most influential descendants
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033942: Thermage Thermacool System (2004), 527 descendants of its own
- K040135: Thermage Thermacool System (2004), 496 descendants of its own

## Indications for use
The Thermage ThermaCool TC System (Model TC) is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K013639
Methodology: https://510kreport.com/methodology