BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850077 · Supplement: S024 · Decision Jun 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
    PMA Number
    P850077
    Supplement Number
    S024
    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
    Decision Code
    APPR
    Decision Date
    June 20, 1997
    Date Received
    May 7, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPOVAL FOR CONSOLIDATED AND REFORMATEED LABELING FOR THE ECLIPSE, SUNFLEX, TORIC 15.0, REVOLUTION, SPORTSOFT, APHAKIC, AND MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ECLIPSE(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, TORIC 15.0(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNFLEX(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, REVOLUTION (TM) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SPORTSOFT(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENSES, SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) APHAKIC EXTENDED WEAR CONTACT LENS, AND SUNSOFT MULTIFOCAL(R) (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES. THE INDICATIONS AND SHELF-LIFE FOR THESE DEVICES REMAIN UNCHANGED FROM THAT PREVIOUSLY APPROVED.

    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