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

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P870024 · Supplement: S054 · Decision Aug 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints
    PMA Number
    P870024
    Supplement Number
    S054
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 13, 2020
    Date Received
    July 22, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new computer numeric control (CNC) lathe process used for contact lens manufacturing.

    Classifications

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

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear