510(k) K191554 ยท GEX Powered Laser Surgical Instrument
LightWalker Laser System Family
| Applicant | Fotona D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | Jun 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191554
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.