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510(k) Data Aggregation

    K Number
    K253039

    Validate with FDA (Live)

    Device Name
    AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
    Manufacturer
    Topcon Corporation
    Date Cleared
    2025-11-07

    (46 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K142417,K180820
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K142417

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TRK-3 OMNIA is a combination of the non-contact tonometer and pachymeter. The device is indicated for automatic measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness.

    Device Description

    TRK-3 OMNIA is a multiple function device, a combination of the auto refractometer, keratometer, non-contact tonometer, and pachymeter. The device is capable of automatic measurement of the refractive errors of the eye; measurement of the corneal curvature of the eye; measurement of intraocular pressure without contacting the eye (with less than 3 diopters of corneal astigmatism); and measurement of central corneal thickness. The device also calculates corneal diameter and pupil distance.

    AI/ML Overview

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