510(k) K222221 ยท GEX Powered Laser Surgical Instrument
DEKA HELIX
| Applicant | El.En Electronic Engineering Spa, Calenzano, IT |
| Decision | Substantially Equivalent, Jan 4, 2023 |
| Received | Jul 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222221
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.