IPL Hair Removal Device (Model: KCA423)

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd with the FDA for Ipl Hair Removal Device (model: Kca423).

Pre-market Notification Details

Device IDK210119
510k NumberK210119
Device Name:IPL Hair Removal Device (Model: KCA423)
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd RM202-203, Y2 Building, Chuangyi Park, Bantian Town, Long Gang District Shenzhen,  CN
ContactCheryl Yang
CorrespondentIris Fung
SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, SCIENTECH Park Guangzhou Economic & Technology Development Guangzhou,  CN
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-05-21

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