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

    GREENLIGHT XPS LASER SYSTEM

    K Number: K092735 · Decision Nov 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    72
    Review Days
    66

    Basic Information

    Device Name
    GREENLIGHT XPS LASER SYSTEM
    K Number
    K092735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Received
    September 4, 2009
    Decision Date
    November 9, 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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