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510(k) Data Aggregation

    K Number
    K091285
    Device Name
    AL T LASER, MODEL AVI HPLL-12
    Manufacturer
    AVICENNA LASER TECHNOLOGY, INC.
    Date Cleared
    2009-07-28

    (88 days)

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

    AVICENNA LASER TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
    Device Description
    The system will produce a 980nm infrared and a 650 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 650 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 650 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
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    K Number
    K031612
    Device Name
    ALT LASER, MODEL VTR 75
    Manufacturer
    AVICENNA LASER TECHNOLOGY, INC.
    Date Cleared
    2003-12-11

    (203 days)

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

    AVICENNA LASER TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
    Device Description
    The system will produce a 980nm infrared and a 660 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 660 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 660 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
    Ask a Question

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