510(k) K183392 ยท GEX Powered Laser Surgical Instrument
PicoLO Nd:YAG Picosecond Laser System
| Applicant | Laseroptek Co., Ltd., Gyeonggido, KR |
| Decision | Substantially Equivalent, Jan 4, 2019 |
| Received | Dec 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183392
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.