Aduro Light Beauty Mask

Light Based Over The Counter Wrinkle Reduction

Shenzhen Kaiyan Medical Co Ltd

The following data is part of a premarket notification filed by Shenzhen Kaiyan Medical Co Ltd with the FDA for Aduro Light Beauty Mask.

Pre-market Notification Details

Device IDK202390
510k NumberK202390
Device Name:Aduro Light Beauty Mask
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Shenzhen Kaiyan Medical Co Ltd 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen,  CN 518101
ContactAlain Dijkstra
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510006
Product CodeOHS  
Subsequent Product CodeILY
Subsequent Product CodeOLP
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-07-14

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