510(k) K180426 ยท GEX Powered Laser Surgical Instrument
Empower H35
| Applicant | Quanta System Spa, Samarate, IT |
| Decision | Substantially Equivalent, Mar 16, 2018 |
| Received | Feb 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180426
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.