BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P850079 · Supplement: S040 · Decision Jun 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)
    PMA Number
    P850079
    Supplement Number
    S040
    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 13, 2002
    Date Received
    May 15, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXTENDED WEAR APPROVAL FOR THE FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES WITH UV ABSORBING MONOMER. THESE DEVICES, PREVIOUSLY CLEARED FOR DAILY WEAR UNDER K020392, WILL BE MARKETED UNDER THE TRADE NAMES LISTED BELOW FOR THE FOLLOWING INDICATIONS FOR USE:FREQUENCY 55 UV AND FREQUENCY 55 UV ASPHERIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED 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. FREQUENCY 55 UV TORIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED FOR THE CORRECTION 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. FREQUENCY 55 UV MULTIFOCAL LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA AND ARE PRESBYOPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION INTO THE CORNEA AND THE EYE. NOTE: ONLY CHEMICAL (NOT HEAT) AND HYDROGEN PEROXIDE DISINFECTION SYSTEMS MAY BE USED WITH FREQUENCY 55 UV LENSES. FREQUENT/PLANNED REPLACEMENT WHEN PRESCRIBED FOR...

    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