BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ALT LASER, MODEL VTR 75

    K Number: K031612 · Decision Dec 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    203

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    Basic Information

    Device Name
    ALT LASER, MODEL VTR 75
    K Number
    K031612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avicenna Laser Technology, Inc.
    Date Received
    May 22, 2003
    Decision Date
    December 11, 2003
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Avicenna Laser Technology, Inc.

    K Number Device Name
    K091285 AL T LASER, MODEL AVI HPLL-12