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

    MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM

    K Number: K082407 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    10
    Review Days
    166

    Basic Information

    Device Name
    MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
    K Number
    K082407
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SANDSTONE MEDICAL TECHNOLOGIES, LLC
    Date Received
    August 21, 2008
    Decision Date
    February 3, 2009
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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