BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

    K Number: K062548 · Decision Nov 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    12
    Review Days
    63

    Basic Information

    Device Name
    MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
    K Number
    K062548
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CONTAMAC LTD.
    Date Received
    August 30, 2006
    Decision Date
    November 1, 2006
    Product Code
    HQD
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by CONTAMAC LTD.

    K Number Device Name
    K182304 Hyper GP (tisilfocon A) Daily Wear Contact Lens
    K161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
    K160859 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
    K081178 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
    K070628 OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
    K033594 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
    K023987 CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
    K023989 CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
    K024045 CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
    K023349 CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
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