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

    VELASII THERAPY LASER SYSTEM

    K Number: K142078 · Decision Oct 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    VELASII THERAPY LASER SYSTEM
    K Number
    K142078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aspen Laser Systems, LLC
    Date Received
    July 31, 2014
    Decision Date
    October 30, 2014
    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 Aspen Laser Systems, LLC

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