510(k) K212703 ยท GEX Powered Laser Surgical Instrument
AcuPulse CO2 Laser System, Delivery Devices and Accessories
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Oct 19, 2021 |
| Received | Aug 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212703
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.