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510(k) Data Aggregation

    K Number
    K971078
    Device Name
    HYDROBRUSH (TM) KERATOME
    Manufacturer
    MEDJET, INC.
    Date Cleared
    1998-01-23

    (305 days)

    Product Code
    HQS
    Regulation Number
    886.4070
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K991124
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Any condition which requires removal of the epithelium from the cornea.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the HydroBrush™ Keratome. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot fulfill your request with the information provided.

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