# K033942: Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Feb 4, 2004 after 47 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: 11 generations back to K943450 (1995). 26 ancestors in all.
527 later devices descend from it; 8 cite it directly.
0 of 554 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K030142: Thermacool TC System, Thermage, Inc. (2003) Summary page 1.

## Most influential descendants
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K060448: Lumenis One Family of Systems; Lumenis One. (2006), 297 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K070004: Accent (2007), 181 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033942
Methodology: https://510kreport.com/methodology