BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S054 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    STAR Excimer Laser System
    PMA Number
    P930016
    Supplement Number
    S054
    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
    February 9, 2018
    Date Received
    December 1, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) the replacement of the existing photo interrupter (3703-0124, manufactured by Hamamatsu) in the Hyperopia Moving assembly (0030-2166) used in the Hyperopia Module (0030-3593) of the STAR S4 IR, with a replacement photo interrupter (3703-0157-L, manufactured by Sharp Microelectronics);2) the replacement of the existing Hall Effect sensor (sensor) (SS21PE) used in the L2 Rotating Cable Assembly (0030-2714) of the STAR S4 IR L2 Rotating Assembly (0030-2508), with a replacement sensor (0035-1010); and 3) the replacement of the existing L2 Cable (0030-2714), with a replacement cable (0030-2035).

    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