IPL Hair Removal Device, Model: AI01

Light Based Over-the-counter Hair Removal

Shenzhen Century Dongyuan Technology Co Ltd.

The following data is part of a premarket notification filed by Shenzhen Century Dongyuan Technology Co Ltd. with the FDA for Ipl Hair Removal Device, Model: Ai01.

Pre-market Notification Details

Device IDK212897
510k NumberK212897
Device Name:IPL Hair Removal Device, Model: AI01
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Century Dongyuan Technology Co Ltd. Floor 2, Building B1, Gonghe Fourth Industrial Zone, Shajing Street, Bao'an District Shenzhen,  CN 518104
ContactHe Wang
CorrespondentYou Yijie
Qimmiq Medical Consulting Service Co., Ltd. Rm.1711, Building K, No.101 Science Ave International Creative Valley Guangzhou,  CN 510663
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-10
Decision Date2021-11-04

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