510(k) K132806 ยท GEX Powered Laser Surgical Instrument
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Jul 11, 2014 |
| Received | Sep 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132806
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.