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

    OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.

    K Number: K070628 · Decision May 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    18
    Review Days
    55

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    Basic Information

    Device Name
    OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
    K Number
    K070628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contamac, Ltd.
    Date Received
    March 7, 2007
    Decision Date
    May 1, 2007
    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
    K212631 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
    K182304 Hyper GP (tisilfocon A) Daily Wear Contact Lens
    K181566 Nutrifill
    K180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
    K171575 ENFLU 18 (enflufocon A) Daily Wear Contact Lens
    K171077 HEXA100 (hexafocon A) Daily Wear Contact Lenses
    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)
    K150590 CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
    K081178 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
    Search all 18 clearances from Contamac, Ltd. →