Leaf Smooth

Light Based Over-the-counter Hair Removal

Shenzhen Leaflife Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Leaflife Technology Co., Ltd with the FDA for Leaf Smooth.

Pre-market Notification Details

Device IDK212697
510k NumberK212697
Device Name:Leaf Smooth
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Leaflife Technology Co., Ltd 4 F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen,  CN 518116
ContactCheng Qiang
CorrespondentCheng Qiang
Shenzhen Leaflife Technology Co., Ltd 4 F,Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen,  CN 518116
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-25
Decision Date2021-11-19

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