510(k) K201663 ยท GEX Powered Laser Surgical Instrument
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jul 16, 2020 |
| Received | Jun 19, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201663
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.