Hair Growth System

Laser, Comb, Hair

Kunshan Bella Optical Technology Co., Ltd.

The following data is part of a premarket notification filed by Kunshan Bella Optical Technology Co., Ltd. with the FDA for Hair Growth System.

Pre-market Notification Details

Device IDK191754
501k NumberK191754
Device Name:Hair Growth System
ClassificationLaser, Comb, Hair
Applicant Kunshan Bella Optical Technology Co., Ltd. Plant 2, Kunshan Development Zone, No. 218 Cheng Hu Road Kunshan,  CN 215300
ContactWu Xuefeng
CorrespondentWu Xuefeng
Kunshan Bella Optical Technology Co., Ltd. Plant 2, Kunshan Development Zone, No. 218 Cheng Hu Road Kunshan,  CN 215300
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-11-22

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