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

    DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER

    K Number: K083288 · Decision Sep 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    472
    Applicant Total
    7
    Review Days
    300

    Basic Information

    Device Name
    DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
    K Number
    K083288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INNOVA VISION INC.
    Date Received
    November 7, 2008
    Decision Date
    September 3, 2009
    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 INNOVA VISION INC.

    K Number Device Name
    K112373 CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
    K073060 CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    K062541 CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
    K053191 DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
    K051129 DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    K033136 I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2