510(k) K131894 ยท GEX Powered Laser Surgical Instrument
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
| Applicant | Nidek Co., Ltd., Gamagori, JP |
| Decision | Substantially Equivalent, Oct 31, 2013 |
| Received | Jun 25, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131894
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.