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510(k) Data Aggregation

    K Number
    K142486
    Device Name
    HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
    Manufacturer
    HEINE Optotechnik GmbH & Co. KG
    Date Cleared
    2015-05-18

    (256 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.
    Device Description
    HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.
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    K Number
    K142837
    Device Name
    HEINE SIGMA 250 & HEINE SIGMA 250 M2
    Manufacturer
    HEINE Optotechnik GmbH & Co. KG
    Date Cleared
    2015-01-29

    (121 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes 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 SIGMA® 250 (M2) are indirect ophthalmoscopes, worn on the user's head to provide illumination and viewing optics in order to examine the media and the retina of a patient`s eye. The indirect ophthalmoscopes are battery operated.
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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
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K131961
    Device Name
    HEINE BETA 200(R) OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2013-12-04

    (160 days)

    Product Code
    HLJ, HIL
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument is designed for examination of the eye. BETA handles are designed exclusively for use with medical examination instruments with bulb illumination.
    Device Description
    The HEINE BETA 200® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eye. It consists of an instrument head and a battery handle that can be attached to the instrument head.
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    K Number
    K131719
    Device Name
    OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
    Manufacturer
    MEDICAL DEVICES (PVT) LTD.
    Date Cleared
    2013-10-30

    (140 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.
    Device Description
    The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.
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    K Number
    K123587
    Device Name
    HEINE MINI 3000 LED OPHTHALMOSCOPE
    Manufacturer
    HEINE OPTOTECHNIK GMBH & CO. KG.
    Date Cleared
    2013-03-22

    (121 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEINE mini 3000® LED 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® LED Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eve. 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.
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    K Number
    K093495
    Device Name
    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
    Manufacturer
    AMERICAN DIAGNOSTIC CORP.
    Date Cleared
    2010-11-19

    (374 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.
    Device Description
    The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
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    K Number
    K070270
    Device Name
    PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
    Manufacturer
    KIRCHNER & WILHELM GMBH + CO.KG
    Date Cleared
    2007-11-05

    (280 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
    Device Description
    All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.
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    K Number
    K052599
    Device Name
    66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
    Manufacturer
    SUZHOU 66 VISION TECH CO., LTD.
    Date Cleared
    2006-11-07

    (412 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.
    Device Description
    Not Found
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    K Number
    K061278
    Device Name
    OPTYSE OPHTHALMOSCOPE
    Manufacturer
    OPHTHALMOS LTD.
    Date Cleared
    2006-05-16

    (8 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Product Code :

    HLJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.
    Device Description
    The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.
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