BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P960019 · Supplement: S001 · Decision Apr 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    MOBILEXCIMER FOR PTK AND PRK
    PMA Number
    P960019
    Supplement Number
    S001
    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
    April 7, 1997
    Date Received
    November 22, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LASERVISION(R)/VISX EXCIMER LASER SYSTEM MODEL C FOR PTK AND PRK TO BE INSTALLED IN THE CALUMET COACH MODEL MMT-436V SEMI-TRAILER COACH, WHICH WILL BE MANUFACTURED BY THE CALUMET COACH COMPANY, 2150 E.DALTON RD., CALUMET CITY, IL 60409-1411. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MOBILEXCIMER(R) FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) THE DEVICE INDICATIONS REMAINED THE SAME

    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