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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K152603
Device Name Green Laser Photocoagulator GYC-500
Applicant
Nidek Co., Ltd.
34-14 Maehama, Hiroishicho
Gamagori,  JP 443-0038
Applicant Contact YONEJI MIZUNO
Correspondent
Nidek Incorporated
47651 Westinghouse Dr.
Fremont,  CA  94539
Correspondent Contact TOSHIO MURATA
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/11/2015
Decision Date 05/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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