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510(k) Data Aggregation

    K Number
    K984537
    Device Name
    KERATOME SYSTEM, MODEL K3000
    Manufacturer
    INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
    Date Cleared
    1999-05-14

    (144 days)

    Product Code
    HMY
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KERATOME SYSTEM, MODEL K3000

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

    The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Keratome System, Model K3000). It acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

    However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The letter is purely an FDA clearance notice, not a study summary.

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