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 |