510(k) K191321 ยท GEX Powered Laser Surgical Instrument
Primelase Excellence
| Applicant | High Technology Products S.L.U, Barcelona, ES |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191321
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.