IPL Hair Removal Device

Light Based Over-the-counter Hair Removal

Shenzhen Noble Smart Manufacturing Tech Co. Ltd

The following data is part of a premarket notification filed by Shenzhen Noble Smart Manufacturing Tech Co. Ltd with the FDA for Ipl Hair Removal Device.

Pre-market Notification Details

Device IDK222598
510k NumberK222598
Device Name:IPL Hair Removal Device
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Noble Smart Manufacturing Tech Co. Ltd 3F, Building A, Zhengchangda Technology Park, Jian'an, Fuhai Town, Bao'an District Shenzhen,  CN 518103
ContactGuo Yi
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen,  CN 518000
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-29
Decision Date2022-11-17

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