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

    EyeArt v2.2.0

    K Number: K223357 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    226

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    Basic Information

    Device Name
    EyeArt v2.2.0
    K Number
    K223357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eyenuk, Inc.
    Date Received
    November 2, 2022
    Decision Date
    June 16, 2023
    Product Code
    PIB
    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
    PIB Diabetic Retinopathy Detection Device

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    Other Clearances by Eyenuk, Inc.

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    K200667 EyeArt