BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Lenses, Soft Contact, Daily Wear

Shenzhen Dashicheng Optical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Dashicheng Optical Technology Co., Ltd. with the FDA for Barbie (polymacon) Daily Wear Soft (hydrophilic) Contact Lens.

Pre-market Notification Details

Device IDK220143
510k NumberK220143
Device Name:BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
ClassificationLenses, Soft Contact, Daily Wear
Applicant Shenzhen Dashicheng Optical Technology Co., Ltd. 101, 201 And 301, Unit 3, Building 1 Wanjiening Industrial Park, No. 1450, Guanguang Road Shenzhen,  CN 518110
ContactJiayi Li
CorrespondentGrace Liu
Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Shenzhen,  CN 518000
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-18
Decision Date2022-09-08

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