BEUDAMED
    Product Code: NFD FDA class 1 21 CFR 886.1160

    Selector, Color, Spectacle, Lens, Tint

    Ophthalmic

    The Selector, Color, Spectacle, Lens, Tint (product code NFD) is an ophthalmic device used to assist in selecting the appropriate tint or color for spectacle lenses, typically a sample display or selection kit used in optical dispensing. It is classified as an FDA Class 1 device within the Ophthalmic specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NFD
    Device Class
    FDA class 1
    Regulation Number
    886.1160
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K012298 THE INTUITIVE COLORIMETER

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.