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

    Lens, Contact (Orthokeratology)

    PMA: P870024 · Supplement: S045 · Decision Jan 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Orthokeratology)
    Trade Name
    FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES
    PMA Number
    P870024
    Supplement Number
    S045
    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
    January 7, 2005
    Date Received
    December 15, 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)