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510(k) Data Aggregation

    K Number
    K180895
    Device Name
    Alleye
    Manufacturer
    Oculocare Medical AG
    Date Cleared
    2018-06-27

    (83 days)

    Product Code
    HOQ
    Regulation Number
    886.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculocare Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alleye is a mobile medical software application indicated for the detection and characterization of metamorphopsia, a visual distortion, in patients with age-related macular degeneration (AMD) and as an aid in the monitoring of the progression of this condition in respect of metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home.
    Device Description
    Alleye is a digital technology visual function test, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Alleye implements an alignment hyperacuity task that helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or monitoring the visual function associated with ongoing treatments. Two elements provide feedback about the Alleye test: a score and a colored circle. The score value reflects the visual performance in the dots alignment, whereas the color indicates whether the performance has worsened considerably (red) or remained stable or improved (green) compared to the previous test.
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