BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P020050 · Supplement: S021 · Decision Jun 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    WAVELIGHT EX500 LASER SYSTEM
    PMA Number
    P020050
    Supplement Number
    S021
    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
    June 2, 2015
    Date Received
    February 27, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).

    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