510(k) K050293 ยท GEX Powered Laser Surgical Instrument
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Mar 18, 2005 |
| Received | Feb 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050293
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.