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510(k) Data Aggregation

    K Number
    K253834

    Validate with FDA (Live)

    Device Name
    VISUREF 600
    Date Cleared
    2026-03-18

    (107 days)

    Product Code
    Regulation Number
    886.1850
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VISUREF 600 is intended to be used to measure the refractive power, corneal radii (Keratometry) and to assist in pre- and post-examination of the human eye.
    VISUREF 600 is a combined autorefractor and keratometer.

    The device supports the following measurements in eye examination of the anterior eye segment:

    • Assessment of the opacity of the lens via retro-illumination.
    • Measurement of tear film break-up time by recording the time between the last complete blink and the first appearance of dark spots in the fluorescein-infilled tear film.
    • Imaging of the meibomian glands located in the upper and lower eyelids using infrared illumination.
    Device Description

    VISUREF 600 is an autorefraction and keratometry device. It can measure the objective refraction of the human eye, including sphere, cylinder, axis and higher order aberrations and the keratometry, including the central and peripheral corneal curvature.

    Additional features are available to complement main use cases of the eye examination device. Those features include:

    • Visual acuity test including variations of contrast and glare
    • Color image observation with optional use of color filters
    • Opacity observation
    • Meibomian gland assessment
    • Measurement of tear film breakup time
    • Measurement of pupil and white-to-white diameter

    The main components are:

    • Chinrest to support patient fixation
    • Measurement unit including light emitting diodes and sensors for measurement as well as target images for the patient to look at
    • User interface display and joystick to control the device operation
    • Printer to print out measurement results
    AI/ML Overview

    N/A

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