510(k) K162837 · GEX Powered Laser Surgical Instrument
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Feb 28, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162837
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.