# K072849: Modification to Thermage Thermacool System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Jan 18, 2008 after 106 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: 13 generations back to K943450 (1995). 31 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 52 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.
- K032088: Modification to Thermacool TC System, Thermage, Inc. (2003) Summary page 1.
- K031046: Thermacool TC System, Thermage, Inc. (2003) Summary page 1.
- K051710: Thermage Thermacool Coupling Fluid, Thermage, Inc. (2005)
- K052778: Thermage Thermacool Skin Marketing, Thermage, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter, Fmd, LLC (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K040340: K-Y Brand Warming Ultragel Personal Lubricant, Personal Products Company, Div. of Mcneil-Ppc, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K090580: Thermage Thermacool NXT System and Accessories (2009), 19 descendants of its own
- K132431: Thermage CPT System (2013), 17 descendants of its own
- K170758: Thermage FLX System and Accessories (2017), 13 descendants of its own
- K230663: Density (2023), 2 descendants of its own
- K221989: The Oligio (2022), 2 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 including upper and lower eyelids Non-invasive treatment of wrinkles and rhytids Temporary improvement in the appearance of cellulite Relief of minor muscle aches and pains Relief of muscle spasms Temporary improvement of local circulation (i.e., blood circulation)

Source page: https://510kreport.com/device/K072849
Methodology: https://510kreport.com/methodology