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510(k) Data Aggregation

    K Number
    K142398
    Device Name
    Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2015-07-14

    (321 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellex Integre Pro Scan is indicated for use photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and structural . abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; . - retinal vein occlusion; - - - wet age-related macular degeneration; : - retinal tears and detachments; - - retinopathy of prematurity; - - Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle . glaucoma
    Device Description
    Not Found
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    K Number
    K122202
    Device Name
    ELLEX 2RT
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2013-07-01

    (341 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of; Clinically Significant Macular Edema (CSME) .
    Device Description
    2RT (model number LR1532) ophthalmic laser system
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    K Number
    K081565
    Device Name
    INTEGRE PRO, MODEL L2RY
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2008-07-02

    (28 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integre family of Ophthalmic laser and Delivery Devices are intended to be used in the treatment of ocular pathology. The Ellex Integre Pro L2RY is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy: - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration; - retinal tears and detachments: - retinopathy of prematurity; - Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
    Device Description
    The Integre Pro L2RY is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. It is capable of producing focused pulses of red or yellow light with wavelengths of 670 nanometres (nm) and 561 nm respectively. The red and vellow beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre Pro L2RY is based upon the Integre Duo LP1RG with a modification to the laser cavity optical components which results in a yellow (561 nm) treatment laser output. As with the Integre Duo, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used. The Integre Pro is an ophthalmic photocoagulator laser designed to be used by ophthalmologists for treatment of ocular pathology of the eye.
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    K Number
    K080423
    Device Name
    INTEGRE, MODEL LP581
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2008-03-11

    (25 days)

    Product Code
    HQF, GEX
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellex Integre is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration; - retinal tears and detachments: - retinopathy of prematurity; - Iridotomy, iridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
    Device Description
    The Integre LP561 is an addition to the Ellex range of ophthalmic photocoagulators. The Integre family are designed for use by ophthalmologists in a clinic or outpatient facility, or in the Retinal Specialist's office. The Integre Duo LP1RG device is capable of producing focused pulses of red or green light with wavelengths of 670 nanometres (nm) and 532 nm respectively. The red and green beams may be used for the same treatments, but the red gives increased penetration of haemorrhaging tissue and fluids, and may also be used to treat ocular melanomas. The Integre LP561 is essentially the same device with a modification to the laser cavity optical components which results in a vellow (561 nm) treatment laser output. The reason for developing the new device is because the yellow wavelength is characterised by high absorption by melanin in the retinal pigment epithelium and choroids that reduces the penetration depth of the beam in the choroids, high absorption by haemoglobin that facilitates direct treatment for retinal/choroidal neovascularisation and no absorption in macular xanthophylls and higher transmission through cloudy media such as cataract or haze on the cornea. As with the Integre LP1RG, the laser pulses are accurately positioned on a structure within the patient's eye with the aid of a delivery device. The delivery device is an integrated slit-lamp microscope. An optional Laser Indirect Ophthalmoscope (LIO) can also be used.
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    K Number
    K052777
    Device Name
    LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2006-03-16

    (164 days)

    Product Code
    GEX, HQF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology. The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation and pan retinal photocoagulation of vascular and . structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - - choroidal neovascularization; - - branch retinal vein occlusion; - - age-related macular degeneration; - retinal tears and detachments; - - retinopathy of prematurity; - - Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma . and open angle glaucoma
    Device Description
    Not Found
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    K Number
    K041598
    Device Name
    LASEREX, MODEL LP4532
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2004-10-06

    (114 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserex LP4532 Ophthalmic Laser is intended for use in the treatment of ocular pathology The Laserex LP4532 is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: - Retinal photocoagulation, pan retinal photocoagulation and intravitreal endophotocognilation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy: - choroidal neovascularization; - branch retinal vein occlusion; - age-refated macular degeneration; - retinal tears and detachments; - retinopathy of prematurity; - macular grid; - macular focal; - Iridotomy, tridectorny, suturelysis and trabeculoplasty in angle closure glaucoma and open angle glaucoma
    Device Description
    Not Found
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    K Number
    K021550
    Device Name
    LUMENIS SELECTA DUET
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2002-08-09

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAPSULOTOMY POSTERIOR IRIDOTOMY / IRIDECTOMY POSTERIOR MEMBRANECTOMY SELECTIVE LASER TRABELULOPLASTY (SLT)
    Device Description
    Not Found
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    K Number
    K003955
    Device Name
    LASEREX INTEGRE, MODEL LP2532
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2001-03-15

    (84 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992824
    Device Name
    LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    1999-11-17

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use for the above product family is: - Iridectomy/Iridotomy. - Posterior Capsulotomy. - Posterior Membranectomies.
    Device Description
    Not Found
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    K Number
    K972514
    Device Name
    LASEREX LP1532 PHOTOCOAGULATOR
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    1997-10-03

    (88 days)

    Product Code
    HQF, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use for this product are; - · Retinal Photocoagulation - · Pan Retinal Photocoagulation - · Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty - - · Endophotocoagulation.
    Device Description
    The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely; - Laser Endoprobes . - Laser Indirect Ophthalmoscope . - Slitlamp Delivery Systems . The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).
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