510(k) K180193 ยท GEX Powered Laser Surgical Instrument
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
| Applicant | El.En Electronic Engineering Spa, Calenzano, IT |
| Decision | Substantially Equivalent, Feb 21, 2018 |
| Received | Jan 24, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180193
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.