BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P970005 · Decision Jul 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    KREMER LASER SYSTEM
    PMA Number
    P970005
    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
    July 30, 1998
    Date Received
    January 31, 1997
    Expedited Review
    N
    Docket Number
    00M-0811

    Advisory Committee Statement

    Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. Patients 21 years and older should not demonstrate a shift greater than 1.0 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