BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930034 · Supplement: S013 · Decision Oct 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    SVS APEX PLUS EXCIMER LASER WORKSTATION
    PMA Number
    P930034
    Supplement Number
    S013
    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
    October 21, 1999
    Date Received
    February 11, 1999
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    00M-1591

    Advisory Committee Statement

    APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.

    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