BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lens, Contact (Other Material) - Daily

    PMA: P860022 · Supplement: S049 · Decision Feb 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Lens, Contact (Other Material) - Daily
    Trade Name
    IPAFLUOROFOCON A AND B
    PMA Number
    P860022
    Supplement Number
    S049
    Device Class
    FDA Class 2
    Product Code
    HQD
    Generic Name
    Lens, contact (other material) - daily
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 6, 1998
    Date Received
    December 22, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017.

    Classifications

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

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily