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

    VISTAKON (METHAFILCON A) CONTACT LENSES

    K Number: K010507 · Decision Apr 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    VISTAKON (METHAFILCON A) CONTACT LENSES
    K Number
    K010507
    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
    February 21, 2001
    Decision Date
    April 12, 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
    K010218 VISTAKON (HEFILCON C) CONTACT LENSES