PerfectSmooth

Light Based Over-the-counter Hair Removal

SHEN ZHEN COSBEAUTY CO.,LTD.

The following data is part of a premarket notification filed by Shen Zhen Cosbeauty Co.,ltd. with the FDA for Perfectsmooth.

Pre-market Notification Details

Device IDK161428
510k NumberK161428
Device Name:PerfectSmooth
ClassificationLight Based Over-the-counter Hair Removal
Applicant SHEN ZHEN COSBEAUTY CO.,LTD. UNIT A- 3F, QIAO DE INDUSTRIAL PARK, TIAN LIAO, GUANG MING GUANG MING DISTRICT Shenzhen,  CN 518000
ContactNicole Hu
CorrespondentYuchen Che
FEIYING DRUG & MEDICAL CONSULTING TECHNICAL SERVICE GROUP RM.3005, AREA B, BLDG.1, SOUTHWARD RUIFENG BUSINESS CENTER, GUIMIAO RD Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-23
Decision Date2017-03-23
Summary:summary

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