BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact, Orthokeratology, Overnight

    PMA: P050031 · Decision Nov 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Lens, Contact, Orthokeratology, Overnight
    Trade Name
    PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
    PMA Number
    P050031
    Device Class
    FDA Class 3
    Product Code
    NUU
    Generic Name
    Lens, contact, orthokeratology, overnight
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 16, 2006
    Date Received
    August 26, 2005
    Expedited Review
    N
    Docket Number
    06M-0473

    Advisory Committee Statement

    APPROVAL FOR THE PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY. THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS. THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.

    Classifications

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

    Product Code Device Name
    NUU Lens, Contact, Orthokeratology, Overnight