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

    CHROMAGEN V3.0 READING AID SOFT CONTACT LENS

    K Number: K012132 · Decision May 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    304

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    Basic Information

    Device Name
    CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
    K Number
    K012132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cantor & Nissel , Ltd.
    Date Received
    July 9, 2001
    Decision Date
    May 9, 2002
    Product Code
    NIC
    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
    NIC Lens, Contact, For Reading Discomfort

    Other Clearances by Cantor & Nissel , Ltd.

    K Number Device Name
    K041700 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
    K022373 CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS