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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
EN
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.

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.