EYE SECRET 38 UV ASPHERIC (POLYMACON) 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 38 Uv Aspheric (polymacon) Soft (hydrophilic) Contact Lens For Daily Wear.

Pre-market Notification Details

Device IDK132854
510k NumberK132854
Device Name:EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
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 Received2013-09-12
Decision Date2013-12-23
Summary:summary

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