510(k) K150907 ยท GEX Powered Laser Surgical Instrument
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
| Applicant | Ellipse A/S, Hoersholm, DK |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | Apr 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150907
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.