Micro-current Facial Cold And Hot Service (model: TPML-100)

Over-the-counter Powered Light Based Laser For Acne

Li-Tek Electronics Technology C0., Ltd

The following data is part of a premarket notification filed by Li-tek Electronics Technology C0., Ltd with the FDA for Micro-current Facial Cold And Hot Service (model: Tpml-100).

Pre-market Notification Details

Device IDK213039
510k NumberK213039
Device Name:Micro-current Facial Cold And Hot Service (model: TPML-100)
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant Li-Tek Electronics Technology C0., Ltd No. 8-13, The Industrial Park Of Jinshagang, Shixia Village, Dalang Town Dongguan,  CN 523106
ContactBarry Yuan
CorrespondentJet Li
Guangdong Jianda Medical Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2022-05-25

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.