Laser Hair Growth Helmet

Laser, Comb, Hair

Kam Yuen Plastic Products Ltd.

The following data is part of a premarket notification filed by Kam Yuen Plastic Products Ltd. with the FDA for Laser Hair Growth Helmet.

Pre-market Notification Details

Device IDK213025
510k NumberK213025
Device Name:Laser Hair Growth Helmet
ClassificationLaser, Comb, Hair
Applicant Kam Yuen Plastic Products Ltd. No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town Zhongshan,  CN 528400
ContactAnna Dan
CorrespondentJett Lee
Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-21
Decision Date2022-05-12

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