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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 DRIVE
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
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