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

    INTELLIWAVE3

    K Number: K100221 · Decision Sep 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    6
    Review Days
    231

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    Basic Information

    Device Name
    INTELLIWAVE3
    K Number
    K100221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Art Optical Contact Lens, Inc.
    Date Received
    January 26, 2010
    Decision Date
    September 14, 2010
    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 Art Optical Contact Lens, Inc.

    K Number Device Name
    K230824 IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
    K172314 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
    K152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
    K142641 Intelliwave4
    K073621 INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT