510(k) K182045 ยท GEX Powered Laser Surgical Instrument
Lotus III Multi-Pulsed Er: Yag Laser System
| Applicant | Laseroptek Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Dec 27, 2018 |
| Received | Jul 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182045
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.