IPL Hair Remover, Model: G993, G996, G998 And G885

Light Based Over-the-counter Hair Removal

Shenzhen Mywin Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Mywin Technology Co., Ltd. with the FDA for Ipl Hair Remover, Model: G993, G996, G998 And G885.

Pre-market Notification Details

Device IDK221679
510k NumberK221679
Device Name:IPL Hair Remover, Model: G993, G996, G998 And G885
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Mywin Technology Co., Ltd. 2nd Floor, Building B, New Age Gongrong Industrial Zone, No. 2, Shihuan Road, Shilong Communit Shenzhen,  CN
ContactMeiyun Liu
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-09
Decision Date2022-07-07

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