BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS

    K Number: K022373 · Decision Oct 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    77

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    Basic Information

    Device Name
    CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
    K Number
    K022373
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cantor & Nissel , Ltd.
    Date Received
    July 22, 2002
    Decision Date
    October 7, 2002
    Product Code
    NJH
    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
    NJH Lens, Spectacle (Prescription), For Reading Discomfort

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NJH), ordered by most recent decision date.

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    FDA 510(k)
    FDA Class 1 ·Ophthalmic
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    Other Clearances by Cantor & Nissel , Ltd.

    K Number Device Name
    K041700 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
    K012132 CHROMAGEN V3.0 READING AID SOFT CONTACT LENS