510(k) K162191 ยท GEX Powered Laser Surgical Instrument
NAVILAS Laser System
| Applicant | Od-Os GmbH, Teltow, DE |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | Aug 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162191
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.