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

    INTRALASE FUSION LASER

    K Number: K063682 · Decision Feb 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    8
    Review Days
    60

    Basic Information

    Device Name
    INTRALASE FUSION LASER
    K Number
    K063682
    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
    INTRALASE CORP.
    Date Received
    December 11, 2006
    Decision Date
    February 9, 2007
    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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    Other Clearances by INTRALASE CORP.

    K Number Device Name
    K073404 IFS LASER SYSTEM
    K041893 INTRALASE FS LASER
    K031960 INTRALASE FS LASER
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    K002890 INTRALASE 600C LASER KERATOME
    K001211 MODIFICATION TO INTRALASE 600C LASER KERATOME
    K993153 INTRALASE 600C LASER KERATOME