BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P060004 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    MEL 80 EXCIMER LASER SYSTEM
    PMA Number
    P060004
    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
    August 11, 2006
    Date Received
    February 14, 2006
    Expedited Review
    N
    Docket Number
    06M-0342

    Advisory Committee Statement

    APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE OF 6.0 TO 7.0 MM IN DIAMETER AND A TRANSITION ZONE OF 1.7 TO 1.9 MM FOR TOTAL ABLATION DIAMETER OF 7.7 TO 8.9 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA OF LESS THAN OR EQUAL TO -7.0 D, WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF LESS THAN OR EQUAL TO -3.0 D, WITH A MAXIMUM MRSE OF -7.00 D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <=0.5D.

    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