510(k) K991634 ยท GEX Powered Laser Surgical Instrument
FOTONA NOVALIS R RUBY LASER SYSTEM
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Aug 10, 1999 |
| Received | May 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991634
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.