# K043402: Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jan 14, 2005 after 35 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: 12 generations back to K943450 (1995). 28 ancestors in all.
124 later devices descend from it; 3 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040135: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K033942: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K021402: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.
- 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.

## Most influential descendants
- K052936: Thermage Thermacool System (2007), 103 descendants of its own
- 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

## Indications for use
The Thermage ThermaCool System is indicated for use in: The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids. Non-invasive treatment of facial wrinkles and rhytids.

Source page: https://510kreport.com/device/K043402
Methodology: https://510kreport.com/methodology