510(k) K160312 ยท GEX Powered Laser Surgical Instrument
FRAXIS DUO
| Applicant | Ilooda Co,., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, Oct 28, 2016 |
| Received | Feb 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160312
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.