Synergy Marble (Model: Opasm)

Light Based Over The Counter Wrinkle Reduction

YRS Group Inc

The following data is part of a premarket notification filed by Yrs Group Inc with the FDA for Synergy Marble (model: Opasm).

Pre-market Notification Details

Device IDK220064
510k NumberK220064
Device Name:Synergy Marble (Model: Opasm)
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant YRS Group Inc 5151 S Procyon St Suite 105 Las Vegas,  NV  89118
ContactRaphael Arvili
CorrespondentDoris Dong
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai,  CN 201613
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-10
Decision Date2022-07-22

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