Light Based Hair Removal Device

Light Based Over-the-counter Hair Removal

Shenzhen GSD Tech Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Gsd Tech Co., Ltd with the FDA for Light Based Hair Removal Device.

Pre-market Notification Details

Device IDK180383
510k NumberK180383
Device Name:Light Based Hair Removal Device
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen GSD Tech Co., Ltd Building A Junsd Hi-Tech Park, West Of Bao'an Rd Watch & Clock Base, Guangming District Shenzhen,  CN 518106
ContactZiyi Gui
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road, S Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-12
Decision Date2018-05-11
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.