510(k) K192331 ยท GEX Powered Laser Surgical Instrument
LaseMD LEO Laser System
| Applicant | Lutronic Global, Billerica MA, US |
| Decision | Substantially Equivalent, Nov 12, 2019 |
| Received | Aug 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192331
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.