BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lens, Contact (Other Material) - Daily

    PMA: P860022 · Supplement: S052 · Decision Feb 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Lens, Contact (Other Material) - Daily
    Trade Name
    BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
    PMA Number
    P860022
    Supplement Number
    S052
    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 4, 2000
    Date Received
    January 5, 2000
    Supplement Type
    THIRTY DAY TRACK
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.

    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