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    K Number
    K131959
    Device Name
    HEINE MINI 3000(R) OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2014-03-07

    (253 days)

    Product Code
    HLJ,DEV
    Regulation Number
    886.1570
    Type
    Abbreviated
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K123587
    Why did this record match?
    Device Name :

    HEINE MINI 3000(R) OPHTHALMOSCOPE

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

    The HEINE mini 3000 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

    Device Description

    The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.

    AI/ML Overview

    This document describes the HEINE mini 3000® Ophthalmoscope and its compliance with relevant standards. Here's a breakdown of the requested information based on the provided text:

    Acceptance Criteria and Device Performance

    The device's acceptance criteria are based on safety limits for optical radiation hazards as defined by the "Ophthalmoscope Guidance" (ISO 10942) and "Ophthalmic instruments - Fundamental requirements and test methods" (ISO 15004-2). The study demonstrates that the HEINE mini 3000® Ophthalmoscope meets these safety requirements.

    Table of Acceptance Criteria and Reported Device Performance:

    ParameterTest SpecificationWavelengthAcceptance Limit (Group 2)Reported Device PerformanceVerdict
    Weighted corneal and lenticular UV, ES-CL, HS-CLThe corneal radiant exposure shall be evaluated by averaging highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 1 mm (7.9 x 10⁻³ cm²).250 - 400 nm3 mJ cm⁻²0.008 µW cm⁻²PASS
    Unweighted corneal and lenticular UV, EUV-CL, HUV-CLThe corneal radiant exposure shall be evaluated by averaging highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 1 mm (7.9 x 10⁻³ cm²).360 - 400 nm1 J cm⁻² (t
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