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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 K192045
Device Name Ophthalmic Yag Laser System YC-200
Applicant
Nidek Co., Ltd.
34-14 Maehama, Hiroishicho
Gamagori,  JP 443-0038
Applicant Contact Tsutomu Sunada
Correspondent
Nidek Incorporated
2040 Corporate Ct.
San Jose,  CA  95131
Correspondent Contact Todd Milholland
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
HJO  
Date Received07/31/2019
Decision Date 11/15/2019
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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