BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850079 · Supplement: S037 · Decision Sep 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    METHAFILCON A
    PMA Number
    P850079
    Supplement Number
    S037
    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
    September 25, 2000
    Date Received
    August 16, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FREQUENCY COLORS CONTACT LENSES IN PHERICAL, ASPHERIC AND TORIC CONFIGURATIONS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS AND FREQUENCY TORIC COLORS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR. THE FREQUENCY COLORS, FREQUENCY ASPHERIC COLORS ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES. THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY OR FOR OCCLUSIVE THERAPY FOR CODITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA. THE FREQUENCY TORIC COLORS LENSES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE ALSO INDICATED TO ENHANCE OR ALTER THE APPARENT COLOR OF THE EYE, INCLUDING OCULAR MASKING, EITHER IN SIGHTED OR NON-SIGHTED EYES THAT REQUIRE A PROSTHETIC CONTACT LENS FOR THE MANAGEMENT OF CONDITIONS SUCH AS CORNEAL, IRIS OR LENS ABNORMALITIES. THE LENS MAY ALSO BE PRESCRIBED FOR THE CORRECTINO OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 12.00 DIOPTERS OR LESS OR FOR OCCLUSIVE THERAPY FOR CONDITIONS SUCH AS DIPLOPIA, AMBLYOPIA OR EXTREME PHOTOPHOBIA.

    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