IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

Light Based Over-the-counter Hair Removal

Shenzhen Semlamp Intelligent Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Semlamp Intelligent Technology Co., Ltd with the FDA for Ipl Hair Removal (model: Sl-b080, Sl-b126, Sl-b136).

Pre-market Notification Details

Device IDK221246
510k NumberK221246
Device Name:IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Semlamp Intelligent Technology Co., Ltd Room 915, Lankun Building, Minkang Road 213, Zhangkeng Community, Minzhi Avenue, Longhua Shenzhen,  CN 518131
ContactQi Wenjun
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510530
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-07

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