BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S002 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    VISX EXCIMER LASER SYSTEM MODELS B AND C
    PMA Number
    P930016
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LZS
    Generic Name
    Excimer laser system
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 7, 1996
    Date Received
    May 16, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1)A PROTOCOL FOR A PROSPECTIVE POSTAPPROVAL STUDY TO DETECT RARE BUT SERIOUS ADVERSE EVENTS; AND, 2)CHANGES TO UPDATE YOUR PHASE III PRK PROTOCOL FOR POSTAPPROVAL FOLLOW-UP PURPOSES. FDA ACKNOWLEDGES THAT SUPPLEMENT 1 (APPROVED ON 15-OCT-96) NEGATES THE NEED FOR A CONTRAST SENSITIVITY/GLARE STUDY OR PROTOCOL. PLEASE NOTE THAT LONG-TERM DATA MUST BE REFLECTED IN THE LABELING (VIA A SUPPLEMENT TO THE PMA) WHEN THE ADD'L FOLLOW-UPS AND/OR POSTAPPROVAL STUDIES ARE COMPLETED

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZS Excimer Laser System