IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C

Light Based Over-the-counter Hair Removal

Shenzhen Ulike Smart Electronics Co.,Ltd

The following data is part of a premarket notification filed by Shenzhen Ulike Smart Electronics Co.,ltd with the FDA for Ipl Hair Removal Device, Model(s): Ui04a, Ui04b, Ui04c.

Pre-market Notification Details

Device IDK221002
510k NumberK221002
Device Name:IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Ulike Smart Electronics Co.,Ltd No.8, Keyuan Road, Yuehai Subb-district, Nanshan District, Shenzhen Shenzhen,  CN 518000
ContactXiaoming Lin
CorrespondentTracy Che
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen,  CN 518052
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-06-01

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