Hair Growth Device

Laser, Comb, Hair

Dongguan Lescolton Medical Equipment Co., Ltd

The following data is part of a premarket notification filed by Dongguan Lescolton Medical Equipment Co., Ltd with the FDA for Hair Growth Device.

Pre-market Notification Details

Device IDK222477
510k NumberK222477
Device Name:Hair Growth Device
ClassificationLaser, Comb, Hair
Applicant Dongguan Lescolton Medical Equipment Co., Ltd 402, Building 1, #3, Xinxing 3rd Road, Jiaoshe, Dongkeng Town Dongguan,  CN 523443
ContactQixiang Liu
CorrespondentShanfeng Jiang
Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City,  CN 510663
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-16
Decision Date2022-11-18

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