510(k) K150516 ยท GEX Powered Laser Surgical Instrument
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
| Applicant | El.En Electronic Engineering Spa, Calenzano, IT |
| Decision | Substantially Equivalent, Apr 13, 2015 |
| Received | Mar 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150516
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.