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510(k) Data Aggregation

    K Number
    K061330
    Device Name
    PSL PORTABLE SLIT LAMP
    Manufacturer
    REICHERT, INC.
    Date Cleared
    2006-05-25

    (13 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Abbreviated
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PSL PORTABLE SLIT LAMP

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

    A slitlamp biomicroscope is intended for use in eye examination of - the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "PSL Portable Slit Lamp". It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The letter is a regulatory document confirming clearance, not a technical report detailing performance study results.

    Therefore, I cannot provide the requested information from this document.

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