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 IDK211185
510k NumberK211185
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 Received2021-04-20
Decision Date2021-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06974879931878 K211185 000
06974879931786 K211185 000
06974879931717 K211185 000
06974879931564 K211185 000
06974879931557 K211185 000
06974879931533 K211185 000
06974879931502 K211185 000
06974879931267 K211185 000

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