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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 K170302
Device Name YELLOW LASER PHOTOCOAGULATOR YLC-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 Received01/31/2017
Decision Date 06/23/2017
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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