510(k) K051113 ยท GEX Powered Laser Surgical Instrument
QUANTA SYSTEM ETRNA GIOVINEZZA
| Applicant | Quanta System Spa, Chelmsford MA, US |
| Decision | Substantially Equivalent, Jan 4, 2006 |
| Received | May 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2013 | Quanta System, S.p.A. Eterna Giovinezza System, Powered Laser Surgical Instrument.
Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.