BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P860040 · Supplement: S013 · Decision Nov 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
    PMA Number
    P860040
    Supplement Number
    S013
    Device Class
    FDA Class 2
    Product Code
    LPL
    Generic Name
    Lenses, soft contact, daily wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 27, 1995
    Date Received
    February 28, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR RELOCATION OF THE ALTERNATE MANUFACTURER, WESTCON CONTACT LENS CO., FROM 2775 CROSSROADS BOULEVARD, #110, GRAND JUNCTION, CO 81506 TO 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 AND FOR A CHANGE IN THE STERILIZATION PROCESS TO INCLUDE PARAMETRIC RELEASE AT WESTCON CONTACT LENS CO., 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 FOR HORIZON 55 SPHERICAL AND HORIZON 55 TORIC (METHAFILCON A) HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR

    Classifications

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

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear