510(k) K180518 ยท GEX Powered Laser Surgical Instrument
GME LinScan Lite 808 Laser System
| Applicant | Gme German Medical Engineering GmbH, Nuremberg, DE |
| Decision | Substantially Equivalent, Jul 23, 2018 |
| Received | Feb 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180518
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.