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 IDK211922
510k NumberK211922
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. 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No. 164, Heping Community 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 Received2021-06-21
Decision Date2021-09-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974879931762 K211922 000
06974879931519 K211922 000
06974879931304 K211922 000
06974879931298 K211922 000
06974879931281 K211922 000
06974879931199 K211922 000
06974879931038 K211922 000
06974879930024 K211922 000

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