# K051710: Thermage Thermacool Coupling Fluid

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jul 19, 2005 after 22 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). 27 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own
- K133212: Zeltiq Coolsculpting System (2014), 30 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 periorbital wrinkles and rhytids * Non-invasive treatment of facial wrinkles and rhytids

Source page: https://510kreport.com/device/K051710
Methodology: https://510kreport.com/methodology