Thermage ThermaCool System
510(k) K033942
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033942 | Date4 Feb 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Thermage ThermaCool System is a non-invasive radiofrequency (RF) device classified as a radiofrequency (RF) generator under product code GEI. It delivers controlled thermal energy to the skin and underlying tissues, promoting collagen remodeling for skin tightening and contouring. The system is designed for dermatologic and general surgical applications, including electrocoagulation and hemostasis. Its primary function is to target periorbital wrinkles and rhytids through localized thermal effects.
The device is supplied as a reusable medical system intended for clinical use in sterile environments. It operates under FDA 510(k) clearance (K033942) and is intended for use in procedures requiring radiofrequency energy. No specific MRI safety classification or single-use designation is stated in the regulatory data. Storage and handling instructions are not provided in the submitted specifications, but standard sterile processing protocols for reusable medical devices apply. The system’s regulatory submission was reviewed by the Surgical Devices Panel (SU) under the General, Plastic Surgery advisory committee.
Other devices from Thermage, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical applications is the Thermage ThermaCool System primarily approved for under its FDA clearance?
The Thermage ThermaCool System is FDA-cleared (510(k) K033942) for non-invasive radiofrequency (RF) treatments targeting periorbital wrinkles and rhytids, promoting skin tightening and contouring through collagen remodeling. It is also designed for dermatologic and general surgical applications like electrocoagulation and hemostasis, though these uses are secondary to its core aesthetic indication.
Is the Thermage ThermaCool System intended for single-use or reusable clinical settings, and how should it be handled?
The Thermage ThermaCool System is explicitly described as a reusable medical device, requiring sterile processing protocols for clinical use. Since no single-use designation is stated, it must be cleaned, disinfected, and sterilized between procedures in accordance with standard reusable medical device guidelines. Sterility is maintained through proper reprocessing rather than disposable packaging.
What types of procedures or treatments can this device be used for beyond skin tightening?
While its primary FDA-cleared use is for collagen remodeling to address periorbital wrinkles, the device’s broader classification as a radiofrequency generator (product code GEI) allows it to be used for electrocoagulation and hemostasis in dermatologic and general surgical contexts. These applications leverage the same RF energy delivery mechanism but are not its intended primary purpose.
How is the device’s regulatory pathway and advisory committee involvement relevant to its clinical use?
The Thermage ThermaCool System’s FDA clearance (K033942) was reviewed by the Surgical Devices Panel (SU) under the General, Plastic Surgery advisory committee, reflecting its dual relevance to both dermatologic and surgical applications. This pathway ensures compliance with standards for RF generators (product code GEI) and confirms its suitability for controlled thermal treatments in clinical settings.