510(k) K083848 ยท GEX Powered Laser Surgical Instrument
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
| Applicant | Alma Lasers , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Apr 14, 2009 |
| Received | Dec 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083848
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.