BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Lens, Contact (Orthokeratology)

    PMA: P870024 · Supplement: S044 · Decision Sep 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Orthokeratology)
    Trade Name
    PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES
    PMA Number
    P870024
    Supplement Number
    S044
    Device Class
    FDA Class 2
    Product Code
    MUW
    Generic Name
    Lens, contact (orthokeratology)
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 24, 2004
    Date Received
    August 31, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF A SPECIFIC PROCESS OF MANUFACTURE TO REDUCE THE HYDRATION TIME AND IMPROVE THE COMFORT FOR THE CONTACT LENS USER.

    Classifications

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

    Product Code Device Name
    MUW Lens, Contact (Orthokeratology)