Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

Lens, Contact, (disposable)

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) 1-day Soft (hydrophilic) Contact Lens.

Pre-market Notification Details

Device IDK143190
510k NumberK143190
Device Name:Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
ClassificationLens, Contact, (disposable)
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 CodeMVN  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-05
Decision Date2015-01-16
Summary:summary

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