510(k) K230373 ยท GEX Powered Laser Surgical Instrument
HELIOS 785 Pico
| Applicant | Laseroptek Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, May 22, 2023 |
| Received | Feb 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230373
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.