510(k) K022838 ยท GEX Powered Laser Surgical Instrument
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Nov 25, 2002 |
| Received | Aug 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022838
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.