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510(k) Data Aggregation

    K Number
    K192755
    Device Name
    Soli-Lite LG4 Galileo
    Manufacturer
    Silhouet-Tone Corporation
    Date Cleared
    2019-12-20

    (81 days)

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

    Silhouet-Tone Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blue (410-415mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Infrared (820-830mm) and Yellow (585-595mm) 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 Soli-Lite LG4 Galileo 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 (620-633nm) - Blue (410-415nm) - Sequence of Yellow (585-595nm) and Infra-red (820-830nm) ● This device is mainly made up of the base (main frame), the head (irradiator), and the lifting stand. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
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