510(k) K203544 ยท GEX Powered Laser Surgical Instrument
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Dec 24, 2020 |
| Received | Dec 4, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203544
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.