510(k) K140670 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
| Applicant | Ellipse A/S, Hoersholm, DK |
| Decision | Substantially Equivalent, Sep 25, 2014 |
| Received | Mar 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2016 | Ellipse A/S Ellipse ND: YAG Laser applicator for Ellipse Multiflex
Medical Laser Products. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.