510(k) K011939 ยท GEX Powered Laser Surgical Instrument
FOTONA DUALIS, FOTONA DUALIS PLUS
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Dec 27, 2001 |
| Received | Jun 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011939
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.