IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

Light Based Over-the-counter Hair Removal

Shenzhen Bosidin Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Bosidin Technology Co., Ltd. with the FDA for Ipl Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130.

Pre-market Notification Details

Device IDK192432
501k NumberK192432
Device Name:IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Bosidin Technology Co., Ltd. Rm. 101 & 201, Bldg. 4, Haoer Jiashitai Technology Park Fengtang Avenue Shenzhen,  CN 518000
ContactWang Jiaoyan
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center Guimiao Road Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-05
Decision Date2019-11-08

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