510(k) K083034 ยท GEX Powered Laser Surgical Instrument
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Oct 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083034
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.