# K000944: Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jul 19, 2000 after 118 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: 6 generations back to K943450 (1995). 18 ancestors in all.
1,069 later devices descend from it; 10 cite it directly.
0 of 1,088 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984552: Cool-Tip RF System, Radionics, Inc. (1999) Summary page 1.
- K981870: Visage Cosmetic Surgery System, Arthrocare Corp. (1998) Summary page 1.
- K951033: Andela Dynamic Cooling Device, Candela Laser Corp. (1996). Our OCR of the scanned summary read K981033, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Candela Dynamic Cooling Device”.

## Most influential descendants
- K013034: Modification to: Thermacool Iia (2001), 800 descendants of its own
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own
- K021149: Aurora DS (2002), 750 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.

Source page: https://510kreport.com/device/K000944
Methodology: https://510kreport.com/methodology