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510(k) Data Aggregation
K Number
K243978Device Name
LED Facial Mask
Manufacturer
Shenzhen Sunsred Technology Co.,Ltd
Date Cleared
2025-06-20
(179 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Sunsred Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses:
For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.
For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.
For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face.
For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Device Description
The LED Facial Mask is a device used for treatment of full-face wrinkles, mild to moderate acne on the face, and providing topical heating. LEDs housed inside the device emit light onto the face. These LEDs generate blue, red, and infrared wavelengths.
This product is composed of the main device, controller, fastening straps, storage bag, blindfold, and charging cable.
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