LED Facial Mask

Over-the-counter Powered Light Based Laser For Acne

Shenzhen OSTO Technology Company Limited

The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Led Facial Mask.

Pre-market Notification Details

Device IDK213056
510k NumberK213056
Device Name:LED Facial Mask
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District Shenzhen,  CN 518100
ContactLi Yang
CorrespondentJett Lee
Guangdong Jianda Medical Technology Co Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2022-07-07

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