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510(k) Data Aggregation

    K Number
    K251507

    Validate with FDA (Live)

    Device Name
    INTEGRE LIO
    Manufacturer
    Date Cleared
    2026-02-06

    (266 days)

    Product Code
    Regulation Number
    886.4390
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The INTEGRE LIO is indicated to be used in ophthalmic laser procedures including retinal photocoagulation.

    Device Description

    The INTEGRE LIO is a laser photocoagulator using visible green diode laser (532nm) technology and provide a compact design to be incorporated in a lightweight headset worn by the physician.

    The INTEGRE LIO is composed of:

    • a battery powered headset based on an indirect ophthalmoscope including a laser enclosure and a Head-Up Display (HUD)
    • a wireless battery powered footswitch.

    INTEGRE LIO is controlled by the wireless footswitch that allows the physician to set the desired parameters for treatment. The physician uses the headset to locate the area to be treated and, after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The physician presses the footswitch to deliver therapeutic green laser light to the targeted tissue. In case the battery is discharged, and the user needs to continue treatment, there is a cable available that connects the footswitch to the headset and an external power supply to connects the footswitch to an electrical outlet.

    The INTEGRE LIO includes laser safety filters that will prevent a laser beam reflection to user's eye. The laser unit must be used with a focusing lens which allows retinal visualization.

    Ancillary personnel must wear appropriate laser safety eyewear to protect their eyes from laser beam

    AI/ML Overview

    N/A

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