510(k) K163196 ยท GEX Powered Laser Surgical Instrument
ACTION II Laser System
| Applicant | Lutronic Corporation, Deogyang-Gu, Goyang-Si, KR |
| Decision | Substantially Equivalent, May 24, 2017 |
| Received | Nov 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163196
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.