Ophthalmic Yag Laser System YC-200

Laser, Ophthalmic

Nidek Co., Ltd.

The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Ophthalmic Yag Laser System Yc-200.

Pre-market Notification Details

Device IDK192045
501k NumberK192045
Device Name:Ophthalmic Yag Laser System YC-200
ClassificationLaser, Ophthalmic
Applicant Nidek Co., Ltd. 34-14 Maehama, Hiroishicho Gamagori,  JP 443-0038
ContactTsutomu Sunada
CorrespondentTodd Milholland
Nidek Incorporated 2040 Corporate Court San Jose,  CA  95131
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOphthalmic
501k Review PanelOphthalmic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-31
Decision Date2019-11-15

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