510(k) K083207 ยท GEX Powered Laser Surgical Instrument
ULTRAWAVE III EX 1320
| Applicant | Quanta System Spa, Solbiate Olona (Va), IT |
| Decision | Substantially Equivalent, Nov 14, 2008 |
| Received | Oct 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083207
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2013 | Quanta System, S.p.A. Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument.
Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangi Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.