Hair Growth System

Laser, Comb, Hair

Xuzhou Kernel Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd. with the FDA for Hair Growth System.

Pre-market Notification Details

Device IDK200929
510k NumberK200929
Device Name:Hair Growth System
ClassificationLaser, Comb, Hair
Applicant Xuzhou Kernel Medical Equipment Co., Ltd. Kernel Mansion, Economic Development District Xuzhou,  CN
ContactWang Jing
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2020-06-03

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