The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Nidek Green Laser Photocoagultor Model Gyc-1000 Connected With The Endophotocoagulation Delivery Unit.
| Device ID | K131894 |
| 510k Number | K131894 |
| Device Name: | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO Gamagori, Aichi, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Yoneji Mizuno NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO Gamagori, Aichi, JP 443-0038 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-10-31 |
| Summary: | summary |