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510(k) Data Aggregation

    K Number
    K122202
    Device Name
    ELLEX 2RT
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2013-07-01

    (341 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELLEX 2RT

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

    The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of; Clinically Significant Macular Edema (CSME) .

    Device Description

    2RT (model number LR1532) ophthalmic laser system

    AI/ML Overview

    This document is a 510(k) clearance letter for the Ellex 2RT ophthalmic laser. It states that the device is substantially equivalent to legally marketed predicate devices for the indication of treating Clinically Significant Macular Edema (CSME) by producing a wound to the Retinal Pigmented Epithelium (RPE) of the retina.

    However, the provided text does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed study parameters requested in the prompt. This document is a regulatory approval notice, not a clinical study report.

    Therefore, I cannot provide the requested information from the provided text.

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