BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850078 · Decision Jan 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    KONTUR 55 EW
    PMA Number
    P850078
    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
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    January 31, 1986
    Date Received
    October 30, 1985
    Expedited Review
    N
    Docket Number
    86M-0109

    Advisory Committee Statement

    APPROVAL FOR THE SPHERICAL AND TORIC CONFIGURATIONS OF THE KONTUR SOFTMETHAFILCON A HY4ROPHILIC CONTACT LENS THE SPHERICAL LENS IS INDICATED FORDAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT APHAKICPERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROP1C THE LENS MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1 50 DIOPTERS D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY THE LENS RANGES 1N POWERS FROM 20 00 D TO 20 00 D THE TORIC LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY 1N NOT APHAKIC PERSONS W1TH NOND1SEASED EYES THAT ARE MYOPIC HYPEROPIC OR HAVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 5 00 D THAT DOES NOT 1NTERFERE WITH VISUAL ACUITY THE LENS CANGES IN POWERS FROM 20 00 D TO 10 00 D BOTH CONFIGURATIONS OF THE LENS ARE TO BE DISINFECTED USING A CHEMICAL LENS CARE SYSTEM.

    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