BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S010 · Decision Oct 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    VISX STAR S2 AND S3 EXCIMER LASER SYSTEM
    PMA Number
    P930016
    Supplement Number
    S010
    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 18, 2000
    Date Received
    June 18, 1999
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    Y
    Docket Number
    01M-0015

    Advisory Committee Statement

    THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS: IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.

    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