IPL Hair Removal Machine

Light Based Over-the-counter Hair Removal

Shenzhen Borria Technology Co.,Ltd

The following data is part of a premarket notification filed by Shenzhen Borria Technology Co.,ltd with the FDA for Ipl Hair Removal Machine.

Pre-market Notification Details

Device IDK213020
510k NumberK213020
Device Name:IPL Hair Removal Machine
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Borria Technology Co.,Ltd 22A, Tianmian City Building, No.4026 Shennan Middle Road, Tianmian Community, Huafu Street, Futian District Shenzhen,  CN 518000
ContactLi Zhenqiang
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2021-12-16

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