BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P850077 · Supplement: S022 · Decision Mar 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
    PMA Number
    P850077
    Supplement Number
    S022
    Device Class
    FDA Class 2
    Product Code
    LPL
    Generic Name
    Lenses, soft contact, daily wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 1997
    Date Received
    November 22, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE MOLDED LENS MANUFACTURING PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SUNSOFT MULTIPLES(TM) AND ARE INDICATED AS FOLLOWS: 1)MULTIPLES TORIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSON WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC AND AHVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 7.00 DIOPTERS (D). 2) MULTIPLES SPHERICAL LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM -20.00 D TO +10.00 D. 3) MULTIPLES APHAKIC LENSES ARE INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC PERSONS WITH NONDISEASED EYES THAT ARE HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1.50 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES RANGE IN POWER FROM +10.50 D TO +20.00 D.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear