BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Excimer Laser System

    PMA: P970056 · Decision Sep 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
    PMA Number
    P970056
    Device Class
    FDA Class 3
    Product Code
    LZS
    Generic Name
    Excimer laser system
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 28, 1999
    Date Received
    November 13, 1997
    Expedited Review
    N
    Docket Number
    01M-0309

    Advisory Committee Statement

    Approval for 16 units of the KERACOR(R) 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder an sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older.

    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