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510(k) Data Aggregation

    K Number
    K221083
    Device Name
    Smartlux Mini
    Manufacturer
    MEDMIX Co., Ltd.
    Date Cleared
    2022-07-12

    (90 days)

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

    MEDMIX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum 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 where applied.
    Device Description
    The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). The device produces light in the following regions of the light spectrum: - · Red (630-640nm) - · Blue (415-425nm) - · Yellow (585-595nm) - Infra-red (820-830nm) This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
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