510(k) K233301 ยท GEX Powered Laser Surgical Instrument
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
| Applicant | Lumenis Be, Ltd., Yokneam Ilit, IL |
| Decision | Substantially Equivalent, Dec 1, 2023 |
| Received | Sep 29, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233301
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.