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

    LUMINEX INFRARED LAMP SYSTEM

    K Number: K082969 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    LUMINEX INFRARED LAMP SYSTEM
    K Number
    K082969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Laser Systems, Inc.
    Date Received
    October 6, 2008
    Decision Date
    October 23, 2008
    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 Medical Laser Systems, Inc.

    K Number Device Name
    K063574 LUMINEX LL LASER SYSTEM