The following data is part of a premarket notification filed by Glan Electronics Co., Ltd. with the FDA for Ipl Hair Removal, Model: Obt-02.
|Device Name:||IPL Hair Removal, Model: OBT-02|
|Classification||Light Based Over-the-counter Hair Removal|
|Applicant||Glan Electronics Co., Ltd. A4 Building, Huafa Industrial Zone, Fuyuan 1st Road, Xinhe Community, Fuyong Town, Bao'an Dist Shenzhen, CN|
SGS-CSTC Standards Technical Services Co., LTD 198 Kezhu Road, ScienTech Park Guangzhou Economic & Tech Development District Guangzhou, CN
|CFR Regulation Number||878.4810 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|