BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lens, Contact, Orthokeratology, Overnight

    PMA: P050031 · Supplement: S009 · Decision May 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Lens, Contact, Orthokeratology, Overnight
    Trade Name
    Paragon Z CRT, Paragon Z CRT Dual Axis
    PMA Number
    P050031
    Supplement Number
    S009
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 10, 2022
    Date Received
    April 15, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new power reader in the manufacturing process, the establishment of a fourth manufacturing line and a change in the blocking process for lens lathing.

    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