510(k) K163449 ยท GEX Powered Laser Surgical Instrument
HyPHo Laser System
| Applicant | Hyper Photonics Srl, Vimercate Mb, IT |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Dec 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163449
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.