BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    UNITY DX (UDX)

    K Number: K252633 · Decision Dec 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    125

    Basic Information

    Device Name
    UNITY DX (UDX)
    K Number
    K252633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cylite Pty. , Ltd.
    Date Received
    August 20, 2025
    Decision Date
    December 23, 2025
    Product Code
    OBO
    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
    OBO Tomography, Optical Coherence

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