510(k) K151331 ยท GEX Powered Laser Surgical Instrument
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jun 30, 2015 |
| Received | May 19, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151331
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.