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510(k) Data Aggregation

    K Number
    K033190
    Device Name
    VISION-TECH YZ SLIT LAMP, MODEL 66
    Manufacturer
    SUZHOU 66 VISION-TECH CO., LTD
    Date Cleared
    2003-12-04

    (64 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K063416,K072861,K080776,K093021
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 66 Vision-Tech YZ Slit lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter from the FDA for a slit lamp. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It mainly focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information based on the provided text.

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