IPL Hair Removal, Model: OBT-02

Light Based Over-the-counter Hair Removal

Glan Electronics Co., Ltd.

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.

Pre-market Notification Details

Device IDK213041
510k NumberK213041
Device Name:IPL Hair Removal, Model: OBT-02
ClassificationLight 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
ContactLisa Pan
CorrespondentIris Fung
SGS-CSTC Standards Technical Services Co., LTD 198 Kezhu Road, ScienTech Park Guangzhou Economic & Tech Development District Guangzhou,  CN
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2021-11-18

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