BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lens, Contact (Other Material) - Daily

    PMA: P860022 · Supplement: S051 · Decision Mar 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Lens, Contact (Other Material) - Daily
    Trade Name
    ITAFLUOROFOCON A AND B
    PMA Number
    P860022
    Supplement Number
    S051
    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
    March 31, 1998
    Date Received
    March 12, 1998
    Supplement Type
    THIRTY DAY TRACK
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for an additional finishing laboratory to become an additional manufacturer and distributor for the device:Diversified Ophthalmics, 1308 West 500 North, Salt Lake City, UT 84116.

    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