510(k) K220467 ยท GEX Powered Laser Surgical Instrument
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
| Applicant | Lumenis Be, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, May 18, 2022 |
| Received | Feb 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220467
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.