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510(k) Data Aggregation
K Number
K223544Device Name
LED light therapy mask (FM-01, FM-02, FM-03)
Manufacturer
Guangdong Newdermo Biotech Co.,Ltd
Date Cleared
2023-02-23
(90 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Newdermo Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Red light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne.
Device Description
LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.
There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).
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