510(k) K053139 ยท GEX Powered Laser Surgical Instrument
FOTONA QX ND:YAG/KTP LASER SYSTEM
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Feb 16, 2006 |
| Received | Nov 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053139
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.