Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

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 55 Uv Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens.

Pre-market Notification Details

Device IDK151586
510k NumberK151586
Device Name:Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
ClassificationLenses, Soft Contact, Daily Wear
Applicant YUNG SHENG OPTICAL CO., LTD. 3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT Taichung City,  TW 42881
ContactWen-han Chen
CorrespondentWen-han Chen
YUNG SHENG OPTICAL CO., LTD. 3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT Taichung City,  TW 42881
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-11
Decision Date2015-08-10
Summary:summary

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