510(k) K192951 ยท GEX Powered Laser Surgical Instrument
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
| Applicant | Ellipse A/S, Hoersholm, DK |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Oct 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192951
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.