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510(k) Data Aggregation
K Number
K214101Device Name
Project E Beauty LED Light Therapy Mask (Model: PE730)
Manufacturer
Date Cleared
2022-03-23
(84 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Duplex International Trading Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.
Device Description
The Project E Beauty LED Light Therapy Mask is a facemask-shaped device designed for home-use, which uses Light Emitting Diodes to emit energy in the red, blue and infrared region of the spectrum. The Project E Beauty LED Light Therapy Mask has a total of 36 LEDs. The red light with wavelengths centered at 635-644nm and the infrared light with wavelengths centered at 845-855nm to treat wrinkles on the face. The blue light with wavelengths centered at 430-445nm and the red light with wavelengths centered at 635-644nm to treat mild to moderate acne on the face. The Project E Beauty LED Light Therapy Mask components include the LED module, USB power cord, and integrated module. The user wears the device over the face, like a pair of glasses, and presses the Power button on the integrated module for 1 second to initiate the treatment. The device has a continuous working time of 12 minutes and powers off automatically.
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