510(k) K162169 ยท GEX Powered Laser Surgical Instrument
EdgeOne CO2 Laser
| Applicant | Jeisys Medical, Inc., Seoul Seoul Teugbyeolsi, KR |
| Decision | Substantially Equivalent, Oct 27, 2016 |
| Received | Aug 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162169
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.