# Thermage, Inc.

- Location (FDA's records): Hayward, CA
- FDA decisions: 18 (2000–2010): 18 510(k) clearances
- Product codes: GEI (17), ONG (1)
- Predicates its devices cite: 48 (37 its own); citations of its devices by later devices: 85 (37 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nikomed U.S.A., Inc.: 2 (https://510kreport.com/company/nikomed-usa)
- Cadwell Laboratories, Inc.: 2 (https://510kreport.com/company/cadwell-laboratories)
- Lpg USA, Inc.: 1 (https://510kreport.com/company/lpg-usa)
- Reliant Technologies, Inc.: 1 (https://510kreport.com/company/reliant-technologies)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Candela Laser Corp.: 1 (https://510kreport.com/company/candela-laser)

## Firms that cite its devices most
- Solta Medical, Inc.: 9 (https://510kreport.com/company/solta-medical)
- Alpha Orthopaedics: 7 (https://510kreport.com/company/alpha-orthopaedics)
- Syneron Medical, Ltd.: 6 (https://510kreport.com/company/syneron-medical)
- Alma Lasers, Inc.: 4 (https://510kreport.com/company/alma-lasers)
- Rhytec Incorporated: 4 (https://510kreport.com/company/rhytec)
- BTL Industries, Inc.: 3 (https://510kreport.com/company/btl-industries)
- Iskra Medical, D.O.O.: 3 (https://510kreport.com/company/iskra-medical-doo)
- Primaeva Medical, Inc.: 2 (https://510kreport.com/company/primaeva-medical)

## Its most-cited devices
- K013639: Thermage Thermacool TC System (2002), cited by 11
- K000944: Thermage Thermacool System (2000), cited by 10
- K033942: Thermage Thermacool System (2004), cited by 8
- K021402: Thermage Thermacool TC System (2002), cited by 7
- K003183: Thermage Thermacool II System (2000), cited by 6
- K053365: Modification to Thermage Thermacool System (2005), cited by 6

## Recent decisions
- K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US (Sep 8, 2010)
- K072849: Modification to Thermage Thermacool System (Jan 18, 2008)
- K052936: Thermage Thermacool System (Jun 12, 2007)
- K061001: Thermassage (Oct 12, 2006)
- K053365: Modification to Thermage Thermacool System (Dec 13, 2005)
- K052778: Thermage Thermacool Skin Marketing (Oct 20, 2005)
- K051710: Thermage Thermacool Coupling Fluid (Jul 19, 2005)
- K043402: Thermage Thermacool System (Jan 14, 2005)

Source page: https://510kreport.com/company/thermage