510(k) K210634 ยท GEX Powered Laser Surgical Instrument
MCL 31 Dermablate System
| Applicant | Asclepion Laser Technologies GmbH, Jena, DE |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Mar 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210634
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.