510(k) K093162 ยท GEX Powered Laser Surgical Instrument
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Jan 22, 2010 |
| Received | Oct 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093162
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.