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510(k) Data Aggregation

    K Number
    K251042
    Device Name
    Light Therapy System (M500, L6)
    Manufacturer
    Guangzhou Ahead Intelligent Technology Co., Ltd.
    Date Cleared
    2025-06-06

    (64 days)

    Product Code
    OHS, OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Ahead Intelligent Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Blue light: Treatment of mild to moderate inflammatory acne. - Red+IR light: Treatment of facial wrinkles. - Amber light: Treatment of facial wrinkles. - Mixed light: Treatment of mild to moderate inflammatory acne.
    Device Description
    The Light Therapy System is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles and mild to moderate inflammatory acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: blue (460nm), amber (605nm), red (630nm) and infrared (850nm), and the device has four light treatment, that is, blue light and mixed light mode to treat acne, while amber light mode and red+ IR mode to treat facial wrinkles. The device is powered by external power supply by connecting with the power adapter and controlled by the controller that should be connected to the main unit. The device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.
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