510(k) K152856 ยท GEX Powered Laser Surgical Instrument
Helios III
| Applicant | Laseroptek Co., Ltd., Sungnam-Si, KR |
| Decision | Substantially Equivalent, Jun 2, 2016 |
| Received | Sep 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152856
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.