510(k) K133319 ยท GEX Powered Laser Surgical Instrument
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Mar 20, 2014 |
| Received | Oct 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133319
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.