The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Green Laser Photocoagulator Gyc-500.
| Device ID | K152603 |
| 510k Number | K152603 |
| Device Name: | Green Laser Photocoagulator GYC-500 |
| Classification | Laser, Ophthalmic |
| Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHICHO Gamagori, JP 443-0038 |
| Contact | Yoneji Mizuno |
| Correspondent | Toshio Murata NIDEK INCORPORATED 47651 WESTINGHOUSE DRIVE Fremont, CA 94539 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2016-05-02 |
| Summary: | summary |