510(k) K182088 ยท GEX Powered Laser Surgical Instrument
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
| Applicant | Fotona D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, Oct 31, 2018 |
| Received | Aug 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182088
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.