Red Wave Hair Removal

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

Shenzhen Accompany Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Accompany Technology Co., Ltd. with the FDA for Red Wave Hair Removal.

Pre-market Notification Details

Device IDK212099
510k NumberK212099
Device Name:Red Wave Hair Removal
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant Shenzhen Accompany Technology Co., Ltd. Unit. 375, Xiangnan Ruifeng Gradan, No. 22, Guimiao Road, Xuefu Community, Nanshan Street, Nanshan District Shenzhen,  CN
ContactYourong Lai
CorrespondentJett Lee
Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2021-09-24

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