IPL Home Use Hair Removal Device

Light Based Over-the-counter Hair Removal

Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd.

The following data is part of a premarket notification filed by Shenzhen Beauty Every Moment Intelligent Electric Co.,ltd. with the FDA for Ipl Home Use Hair Removal Device.

Pre-market Notification Details

Device IDK221001
510k NumberK221001
Device Name:IPL Home Use Hair Removal Device
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd. Rm.101,201,501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No.164, Zhancheng Co Shenzhen,  CN 518100
ContactLuo Huajun
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974879931984 K221001 000
06974879931977 K221001 000
06974879931892 K221001 000
06974879931861 K221001 000
06974879931854 K221001 000
06974879934862 K221001 000
06974879933865 K221001 000
06974879932868 K221001 000

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