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

    Lens, Contact, Orthokeratology, Overnight

    PMA: P040029 · Supplement: S019 · Decision Feb 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Lens, Contact, Orthokeratology, Overnight
    Trade Name
    Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
    PMA Number
    P040029
    Supplement Number
    S019
    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
    February 8, 2021
    Date Received
    January 14, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of manufacturing alternatives for the Euclid Systems Orthokeratology (oprifocon A) Toric Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Toric Contact Lenses for Overnight Wear.

    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