Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens For Daily Wear

Lenses, Soft Contact, Daily Wear

Yung Sheng Optical Co., Ltd

The following data is part of a premarket notification filed by Yung Sheng Optical Co., Ltd with the FDA for Eye Secret 59 Uv Aspheric (omafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.

Pre-market Notification Details

Device IDK213983
510k NumberK213983
Device Name:Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens For Daily Wear
ClassificationLenses, Soft Contact, Daily Wear
Applicant Yung Sheng Optical Co., Ltd No. 8, Keya 2nd Road, Daya District Taichung City,  TW 428
ContactWen-Han Chen
CorrespondentWen-Han Chen
Yung Sheng Optical Co., Ltd No. 8, Keya 2nd Road, Daya District Taichung City,  TW 428
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-09-02

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