510(k) K180597 ยท GEX Powered Laser Surgical Instrument
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Apr 3, 2018 |
| Received | Mar 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180597
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.