Thermage, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Thermage, Inc. makes
Thermage, Inc. manufactures non-invasive skin treatment devices, including radiofrequency-based systems like the Thermage Thermacool series for skin tightening and remodeling. The company also produces fractional laser systems, such as the Fraxel Re:Store Dual Laser, designed for skin resurfacing and rejuvenation. Modifications to existing systems are part of the portfolio, ensuring tailored solutions for aesthetic and cosmetic procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database. Thermage, Inc. is headquartered in the United States.
Catalogue
Search and filter all 18 devicesFDA recalls
FDA recall records list 1 recall initiated by Thermage, Inc., initiated on 2002-12-09. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 9 Dec 2002 Z-0556-03 Unclassified (pre-2012) Terminated Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
Full distribution text
- 9 Dec 2002 Z-0556-03 Unclassified (pre-2012) Terminated Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
Frequently asked questions
How many devices does Thermage, Inc. have in the registry?
The registry currently lists 18 devices for Thermage, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thermage, Inc.'s devices?
Among its 18 most recently registered devices, Thermage, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Thermage, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Thermage, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Thermage, Inc.?
FDA recall records list 1 recall initiated by Thermage, Inc., the most recent initiated on 9 Dec 2002. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Thermage, Inc. in the registry?
The most recently registered devices listed for Thermage, Inc. include THERMASSAGE, MODIFICATION TO: THERMACOOL IIA, THERMAGE THERMACOOL SYSTEM and FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US.