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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P960039 · Decision Apr 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
    PMA Number
    P960039
    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    Approved (Withdrawn)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
    April 17, 1997
    Date Received
    October 30, 1996
    Expedited Review
    N
    Docket Number
    97M-0272

    Advisory Committee Statement

    APPROVAL FOR THE SOFT-55 EW APHAKIC (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS (AFTER CATARACT SURGERY) THAT ARE MYOPIC OR HYPEROPIC. SOFT-55 EW APHAKIC LENSES MAY BE WORN BY PERSONS WHO MAY EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY

    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