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510(k) Data Aggregation

    K Number
    K252633

    Validate with FDA (Live)

    Device Name
    UNITY DX (UDX)
    Manufacturer
    Cylite Pty. , Ltd.
    Date Cleared
    2025-12-23

    (125 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    22 - 120
    Reference & Predicate Devices
    K191051,K231760,K173771
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including:

    • Axial Length
    • Anterior Chamber Depth
    • Central Corneal Thickness
    • Lens Thickness

    The Reference Image functionality is intended for use as an ocular image capture tool.

    Device Description

    The UNITY DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including axial length, anterior chamber depth, corneal thickness, lens thickness, and reference image. The UNITY DX device has four (4) measurement modalities: HP-OCT, wavefront measurement, reference image, and reflective topography.

    AI/ML Overview

    N/A

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