BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P870024 · Supplement: S058 · Decision Apr 23, 2021
    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 HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints
    PMA Number
    P870024
    Supplement Number
    S058
    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
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 2021
    Date Received
    January 21, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new manufacturing facility located at Paragon Vision Sciences, Inc., 2120 W Guadalupe Rd. Gilbert, Arizona.

    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