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.
|Device Name:||IPL Hair Removal Device|
|Classification||Light 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|
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000
|CFR Regulation Number||878.4810 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|