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510(k) Data Aggregation

    K Number
    K152429
    Device Name
    Slit Lamp Microscope
    Manufacturer
    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD.
    Date Cleared
    2016-05-11

    (259 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MediWorks Model S series Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

    Device Description

    AC-powered slit lamp biomicroscopes

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Mediworks Precision Instruments Co., Ltd. for a Slit Lamp Microscope. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory requirements. Therefore, I cannot fulfill your request based on the given input.

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