# K053365: Modification to Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Dec 13, 2005 after 11 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
No predicates in its family tree.
203 later devices descend from it; 6 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070004: Accent (2007), 181 descendants of its own
- K060948: Portrait PSR3 (2006), 110 descendants of its own
- K071786: Portrait PSR (2007), 109 descendants of its own
- K072394: Portrait Stand-Off (2007), 104 descendants of its own
- K073572: Matrix RF Applicator (2008), 102 descendants of its own

## Indications for use
The Thermage ThermaCool System is indicated for use in: Dermatologic and general surgical procedures for electro coagulation and hemostasis Non-invasive treatment of wrinkles and rhytids

Source page: https://510kreport.com/device/K053365
Methodology: https://510kreport.com/methodology