510(k) K212663 ยท GEX Powered Laser Surgical Instrument
HELIOS IV 785
| Applicant | Laseroptek Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jun 9, 2022 |
| Received | Aug 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212663
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.