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510(k) Data Aggregation

    K Number
    K242638
    Device Name
    LED Light Therapy Machine (G1, G3, G4, G6)
    Date Cleared
    2024-11-27

    (85 days)

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

    Shenzhen Walton Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    The LED Light Therapy Machine, Models: G1, G3, G4, G6, is an LED phototherapy device for over-the-counter (OTC) use. The device package includes the LED Light Therapy Machine, an electrical adaptor to power the device, eye safety goggles, and a user manual. The device will automatically stop the treatment after a preset time. The device contains LEDs that emit light at 460 nm (blue), 620 nm (red), and/or 850 nm (infrared). The device can emit blue light only, red light only, infrared only, or blue light plus infrared light simultaneously.
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