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510(k) Data Aggregation

    K Number
    K142256
    Device Name
    Applied BioPhotonics Phototherapy System ABPT1003
    Date Cleared
    2015-01-07

    (146 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED BIOPHOTONICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Applied BioPhotonics® Phototherapy System ABPT1003 is intended to provide phototherapeutic light to the body. The device emits: - Red and infrared light to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Applied BioPhotonics® Phototherapy System ABPT1003 is a light therapy device using specific wavelengths of polychromatic energy produced by super-luminous light emitting diodes (LEDs) to treat a variety of skin and body conditions. The device can be described as a Class II Low Level Light treatment process employing the application of light and heat, which penetrates the skin surface to the underlying tissues, triggering normal cellular functions. This technology is commonly referred to as photobiostimulation, light emitting diode therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive. Using patent pending and proprietary techniques and computational processes, the Applied BioPhotonics® Phototherapy System ABPT1003 is composed of: - Proprietary hardware (i.e. ABLM1002 LightMachine) - LightOS software (running in the LightMachine) - LightPad sets (ABLP103) comprising flexible, aseptic, polymeric LED pads - Cables (for connecting LightPads and LightMachines) The IR and red spectrum emitted from LEDs in the ABLP103 LightPad sets is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. The LightMachine control panel displays to the operator what treatment is being performed and provides the user with a choice of driving one or two LightPad sets with any chosen treatment protocol. The software component of the device controls the user's selection of specific treatment protocols on the LightMachine's control panel. The treatment may be set manually by entering LED-operating conditions (i.e. wavelength, duration, and pulse frequency) or by selecting preset treatment protocols. The software is revision-controlled and can be upgraded by the manufacturer. This is a prescription use only device. The labeling, instructions and user operations are designed for health care professionals.
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