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

    Lenses, Soft Contact, Extended Wear

    PMA: P080011 · Supplement: S201 · Decision May 4, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity Multifocal
    PMA Number
    P080011
    Supplement Number
    S201
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 4, 2026
    Date Received
    April 10, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    introduction of a Syncro Lens Packaging Machine at the CooperVision, Inc. facility located in West Henrietta, New York

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear