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

    ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS

    K Number: K984098 · Decision May 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
    K Number
    K984098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adventures IN Color Technology, Ltd.
    Date Received
    November 17, 1998
    Decision Date
    May 10, 1999
    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 Adventures IN Color Technology, Ltd.

    K Number Device Name
    K992054 ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS