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

    VISTAKON (HEFILCON C) CONTACT LENSES

    K Number: K010218 · Decision Mar 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    472
    Applicant Total
    5
    Review Days
    51

    Basic Information

    Device Name
    VISTAKON (HEFILCON C) CONTACT LENSES
    K Number
    K010218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VISTAKON
    Date Received
    January 24, 2001
    Decision Date
    March 16, 2001
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by VISTAKON

    K Number Device Name
    K042275 VISTAKON (SENOFILCON A) SOFT CONTACT LENS
    K033969 ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
    K013973 ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC
    K010507 VISTAKON (METHAFILCON A) CONTACT LENSES