510(k) K203491 ยท GEX Powered Laser Surgical Instrument
PicoLO Nd: YAG Picosecond Laser System
| Applicant | Laseroptek Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Apr 7, 2021 |
| Received | Nov 27, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203491
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.