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510(k) Data Aggregation
K Number
K243423Device Name
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
Manufacturer
Shenzhen Rainbow Technology Co., Ltd.
Date Cleared
2025-01-28
(85 days)
Product Code
OHS, ILY, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Rainbow Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Red+Infrared light: Treatment of full-face wrinkles.
- Red light: Treatment of full-face wrinkles.
- 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.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Device Description
The LED Light Therapy Mask adopts light emitting diodes (LED) in the infrared, red and blue spectrum to irradiate on the skin. The face will absorb the light energy to achieve the effects. The LED Light Therapy Mask is applied directly to the skin to ensure consistent administration of light during each treatment. LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce wrinkles and arovide topical heating, It is consisting of main unit(mask), controller, Type-C charging cable and so on.
The RB-081 outputs 5 kinds of treatment modes: red infrared, blue, red+blue light. The RB-030 outputs 4 kinds of treatment modes: red-infrared, red, infrared, blue light. The RB-008 outputs 3 kinds of treatment modes: red+infrared, red, blue light. The RB-008G/ RB-008GB/RB-008J/RB-008JB output 4 kinds of treatment modes: red+infrared, red, blue light.
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