Looper (Model: ZX-579S)

Over-the-counter Powered Light Based Laser For Acne

Heat In A Click LLC

The following data is part of a premarket notification filed by Heat In A Click Llc with the FDA for Looper (model: Zx-579s).

Pre-market Notification Details

Device IDK202055
510k NumberK202055
Device Name:Looper (Model: ZX-579S)
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant Heat In A Click LLC 1975 Tigertail Blvd Dania Homestead,  FL  33034
ContactGuy Levi
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510006
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-24
Decision Date2021-04-16

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