Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251353

    Validate with FDA (Live)

    Device Name
    Eyer 2
    Date Cleared
    2026-01-16

    (261 days)

    Product Code
    Regulation Number
    886.1120
    Age Range
    N/A
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K152869

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description

    The Eyer 2 is accompanied by accessories: frontal module for the ocular surface (1pc), dock station (charging station) (1pc), eye cap (1pc), lens protector (1 pc), storage case (1 pc), cleaning cloth (1 pc), allen wrench (1 pc), quick start guide (1 pc), welcome card (1 pc), shipping box (1 pc), power supply (1 pc), slit-lamp adapter (1 pc), silica gel bags (2 pcs).

    Eyer 2 is designed for use in a medical environment by healthcare professionals. Captured images and videos are used for documentation and consultation. The images and videos are securely stored in an internal smartphone application database.

    For the retinal function, the Eyer 2 is designed for non-mydriatic fundus imaging. In non-mydriatic imaging, no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer 2 has fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the optical disc in the center by selecting the appropriate point.

    For the ocular surface and surrounding areas function, Eyer 2 has an ocular surface module with white, blue, and infrared light sources for imaging the eye surface and surrounding areas; in this configuration, the device does not make contact with the patient.

    The transfer of images to a PC is carried out via DICOM, DICOMWEB, FTPS, or local folder connections, with the client responsible for the connection and subsequent storage.

    The Eyer 2 energy comes from the smartphone that has a rechargeable Li-Ion battery and is charged when the device is docked on the charge station, which is connected to the mains by a power supply cable.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1