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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 K203130
Device Name Ophthalmic Yag Laser System YC-200
Applicant
Nidek Co., Ltd.
34-14 Machama, Hiroishicho
Gamagori,  JP 443-0038
Applicant Contact Tsutomu Sunada
Correspondent
Nidek Incorporated
2040 Corporate Court
San Jose,  CA  95131
Correspondent Contact Todd Milholland
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Codes
GEX   HJO  
Date Received10/19/2020
Decision Date 12/07/2020
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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