Laser Hair Growth Comb

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 Comb.

Pre-market Notification Details

Device IDK213027
510k NumberK213027
Device Name:Laser Hair Growth Comb
ClassificationLaser, Comb, Hair
Applicant Kam Yuen Plastic Products Ltd No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town ZhongShan,  CN 528400
ContactAnna Dan
CorrespondentJett Lee
Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN 510000
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-21
Decision Date2022-05-26

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