510(k) K980560 ยท GEX Powered Laser Surgical Instrument
FOTONA SKINPLUS LASER SYSTEM
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Mar 27, 1998 |
| Received | Feb 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980560
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.