510(k) K101306 ยท GEX Powered Laser Surgical Instrument
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Jul 1, 2011 |
| Received | May 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101306
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.