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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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    K Number
    K120460
    Device Name
    SMARTLUX
    Manufacturer
    MEDMIX CO., LTD
    Date Cleared
    2012-10-01

    (229 days)

    Product Code
    GEX
    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
    633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions 415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris 830nm wave length : 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
    SMARTLUX is light therapy system using two kinds of wave length light and infrared ray. It has four type of head which is including red, blue and IR respectively. Heads are chanqeable by user and assembled head is identified automatically after changing head and user interface is also changed according to each head. For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software.
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