510(k) K192269 ยท GEX Powered Laser Surgical Instrument
TwinScan 808/755 Laser System
| Applicant | Gme German Medical Engineering GmbH, Nuremberg, DE |
| Decision | Substantially Equivalent, Nov 19, 2019 |
| Received | Aug 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192269
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.