510(k) K132431 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
THERMAGE CPT SYSTEM
| Applicant | Solta Medical, Inc., Hayward CA, US |
| Decision | Substantially Equivalent, Sep 6, 2013 |
| Received | Aug 5, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2019 | Solta Medical Inc Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgic Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.