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510(k) Data Aggregation

    K Number
    K252348

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-18

    (142 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

    The OA-2000 is a non-invasive, non-contact biometer intended for obtaining ocular measurements to assist in the determination of the appropriate power of an intraocular lens for implantation. The OA-2000 measures: Axial length, corneal thickness, anterior chamber depth and lens thickness.

    Device Description

    The Tomey OA-2000 ophthalmic optical coherence biometer is an ophthalmology device used to measure the length of living tissue utilizing light interference technology and to measure the corneal shape on captured images. This device is designed to measure axial length, anterior chamber depth, corneal thickness, crystalline lens thickness, and corneal shape.

    The instrument contains an internal database and has various IOL power formulae applicable to ordinary cataract surgery and/or cataract surgery of eyes with corrected corneal refractive power and provides data necessary to assist the physician in determining IOL power.

    The OA-2000 biometer is equipped with a 10.4-inch large touch-screen monitor for ease of use and includes Auto Alignment and Auto Shot functions. Manual measurement is also available in the event that automatic measurement is difficult.

    Fourier-domain optical biometry is a high-resolution, non-invasive optical measurement technique based on the principle of low-coherence interference. It is used to determine the distance or depth of reflective structures. Fourier-domain optical biometry is based on the principle of low-coherence interferometry. A low-coherence light source is split into two beams: one directed toward a reference mirror, and the other toward the patient's eye. Light reflected from both the reference and sample arms is combined to produce an interference pattern, but only if the optical path lengths of the two arms are closely matched. This interference signal indicates the location of reflective structures in the sample and is used to reconstruct depth-resolved images or measurements.

    AI/ML Overview

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