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

    59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

    K Number: K040303 · Decision Feb 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    472
    Applicant Total
    2
    Review Days
    359

    Basic Information

    Device Name
    59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
    K Number
    K040303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HYDROGEL VISION CORPORATION
    Date Received
    February 9, 2004
    Decision Date
    February 2, 2005
    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 HYDROGEL VISION CORPORATION

    K Number Device Name
    K051430 EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)