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510(k) Data Aggregation

    K Number
    K023004
    Device Name
    LFRE INDIRECT LARYNGOSCOPE
    Manufacturer
    ASTRALITE CORP.
    Date Cleared
    2003-01-28

    (141 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LFRE Indirect Laryngoscope may be used for examinations of the larynx and nasopharynx

      1. while conducting normal, routine physical examinations.
      1. while inspecting for causes of abnormal conditions (e.g., hoarseness, pain) presented by the patient.
      1. while inspecting for causes of abnormal conditions indicated by referring facilities.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, granting clearance for the Astralite Corporation's LFRE Indirect Laryngoscope. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting novel performance data against specific acceptance criteria in the way a clinical trial or performance study would.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's clearance for specific indications for use, but it does not detail the technical performance criteria or studies that might have been part of the manufacturer's submission for substantial equivalence.

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