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510(k) Data Aggregation

    K Number
    K973064
    Device Name
    KEELER TEARSCOPE-PLUS
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Date Cleared
    1998-04-07

    (232 days)

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

    KEELER TEARSCOPE-PLUS

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

    Specular Observation of the tear film

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the KEELER TEARSCOPE-PLUS. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the acceptance criteria, details of a study proving the device meets those criteria, or any information about AI/algorithm performance.

    The 510(k) process primarily evaluates substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness information, often relying on comparisons to existing devices rather than new performance studies with pre-defined acceptance criteria in the way you've described.

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

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