LED Light Therapy Device

Over-the-counter Powered Light Based Laser For Acne

Uvbiotek, LLC

The following data is part of a premarket notification filed by Uvbiotek, Llc with the FDA for Led Light Therapy Device.

Pre-market Notification Details

Device IDK180900
510k NumberK180900
Device Name:LED Light Therapy Device
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant Uvbiotek, LLC 3 Depot Street, Hudson Falls New York,  NY  12839
ContactDave Oberhelman
CorrespondentJinghua Zhou
Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou,  CN 511660
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-06
Decision Date2018-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B3437000CA1 K180900 000

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