510(k) K191501 ยท GEX Powered Laser Surgical Instrument
PALLAS 308/311 Solid-State UV Laser System
| Applicant | Laseroptek Co., Ltd., Gyeonggido, KR |
| Decision | Substantially Equivalent, Jan 3, 2020 |
| Received | Jun 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191501
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.