BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P990018 · Decision Jul 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    MENICON Z RIGID GAS PERMEABLE CONTACT LENS
    PMA Number
    P990018
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 2000
    Date Received
    March 18, 1999
    Expedited Review
    N
    Docket Number
    00M-1414

    Advisory Committee Statement

    APPROVAL FOR THE MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE LENS. MENICON Z(TM) (TISILFOCON A) SPHERICAL OR ASPHERIC LENSES AND NON-PRISM BALLAST TORIC LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PRACTITIONER) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE DISINFECTED USING A...

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear