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The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS™ HD-OCT Reference Database is a quantitative tool used for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of healthy subjects. CIRRUS™ HD-OCT AngioPlex angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS™ HD-OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The subject device is a computerized instrument that acquires and analyses cross-sectional tomograms of anterior ocular structures (including comea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. CIRRUS 6000 has a 100kHz scan rate for all structural and angiography scans. The subject device uses the same optical system, and principle of operation as the previously cleared CIRRUS 6000 (K222200) except for the reference database functionality. The subject device contains a newly acquired reference database which was collected on K222200. This study data compares macular thickness, ganglion cell thickness, optic disc and RNFL measurements to a reference range of healthy eyes as guided by the age of the patient and /or optic disc size. Reference database outputs are available on Macular Cube 200x200, and Optic Disc Cube 200x20 scan patterns. All other technical specifications have remained the same as the predicate K222200.

VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy. This device is for Prescription Use (Rx) only.

VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.

· INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery. · YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800 option) are an accessory to surgical microscope and are intended for viewing and visual assessment of intra-operative blood flow as well as aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. The functionality of these filters is derived from their ability to hight fluorescence emitted from tissue that has been treated with a fluorescence agent by applying appropriate wavelengths of light and utilizing selected filters. This helps a surgeon to visualize different structural body elements (such as vessels, tissue, blood flow, occlusions, aneurysms, etc.) during various intraoperative procedures. The fluorescence accessory can be activated by the user via the Graphical User Interface (GUI), foot control panel or the handgrips, for example. For these accessories to be used with a qualified surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of YELLOW 560 and INFRARED 800 with FLOW 800 Option. The fluorescence accessories are embedded into the surgical microscope. The emission filter wheels are present within the head of the microscope. For filter installation into the surgical microscope, two emissions filters (one for each eyepiece) are placed into each of these filter wheel is present in front of the light source, which is installed along with the excitation filter

CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing and measuring and posterior ocular structures, including corneal epithelium, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. CIRRUS' AngioPlex OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma. This device is Prescription Use (Rx) only.

The CIRRUS™ HD-OCT Model 6000 is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures. The clinical purpose of this device has not been modified as compared to the predicate. CIRRUS 6000 uses the same optical system, architecture, and principle of operation as the previously cleared CIRRUS 5000 (K181534). CIRRUS 6000 has a 100 kHz scan rate for all structural and angiography scans. The primary impact of the higher acquisition speed is its impact on signal-to-noise ratio. The signal-to-noise ratio m the subject device is calibrated to match the specifications of the CIRRUS 6000 uses the same segmentation algorithms as the predicate device and therefore the segmentation results will be equivalent. In addition to the acquisition speed change, CIRRUS 6000 also has a wider field of view (FOV) and has increased the number of fixation points to 21.

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The CIRRUSTM HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive optical technique. CIRRUS HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye). The CIRRUS HD-OCT is offered in four models, Model 4000, 400, 5000 and 500. In the CIRRUS HD-OCT Models 4000 and 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Models 400 and 500 are similar to the Models 4000 and 5000 except that they provide the fundus image using the OCT scanner only. The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuro-retinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness. In addition to macular and optic disc cube scans, the CIRRUS HD-OCT also offers scans for OCT angiography imaging, a non-invasive approach with depth sectioning capability to visualize microvascular structures of the eye. Anterior segment scans enable analysis of the anterior segment including Anterior Chamber Depth. Angle-to-Angle and automated measurement of the thickness of the cornea with the Pachymetry scan.

The INTRABEAM® System is a system for radiotherapy treatment. Indications for Use: INTRABEAM Flat Applicator The INTRABEAM® Flat Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System. - During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. - During treatment of tumors on the body surface. The INTRABEAM® Flat Applicator is designed to deliver a flat radiation field at a distance of 5 mm from its circular application surface in water. Indications for Use: INTRABEAM Surface Applicator The INTRABEAM® Surface Applicator is intended to supply a specified radiation dose during applications exclusively in combination with the INTRABEAM System. - During intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed. - During treatment of tumors on the body surface. The INTRABEAM® Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the turnor cavity. The INTRABEAM Flat Applicator and INTRABEAM Surface Applicator are accessories to the INTRABEAM System that have been developed to provide radiotherapy to cancer lesions at or near the tissue surface. There are six sizes of INTRABEAM Flat Applicators in a set. The sizes are 1.0 cm, 2.0 cm, 3.0 cm, 4.0 cm, 5.0 cm and 6.0 cm in diameter. The INTRABEAM Surface Applicators are available in the four sizes. These sizes are 1.0 cm, 2.0 cm and 4.0 cm. The four smaller sizes of INTRABEAM Flat Applicators (size 1.0 to 4.0 cm) have the same dimensions and appearance as the INTRABEAM Surface Applicators (sizes 1.0 to 4.0 cm). The INTRABEAM System has a maximum voltage of 50 kV and a maximum current of 40 µA. The INTRABEAM Flat Applicator and the INTRABEAM Surface Applicator provide a uniform dose of radiotherapy distributed across a flat surface. The applicators are made from the same materials. From a technical point of view, the INTRABEAM Flat and Surface Applicators are basically the same, but are optimized for treating different tissue depths.

The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The CIRRUS photo is a non-contact, high resolution digital, tomographic and biomicroscopic imaging device that merges fundus imaging and optical coherence tomography into a single device. To optimize the workflow, the system applies the same beam delivery system for imaging and scanning.

The Cirrus™ HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The Cirrus normative databases are quantitative tools for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The Cirrus HD-OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye). The Cirrus HD-OCT is offered in two models, Model 4000 and Model 400. In the Cirrus HD-OCT Model 4000 instrument, the fundus camera is a line scanning ophthalmoscope. The Cirrus HD-OCT Model 400 is similar to the Model 4000 except that it provides the fundus image using the OCT scanner only. The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness. Visit-to-visit comparison of images and measurements is available for the macula. Specifically, change in macular thickness, area and volume of Retinal Pigment Epithelium (RPE) elevations, area of sub-RPE illumination and distance of Sub-RPE illumination to the fovea. Change analysis of multiple visits, up to eight, can be performed for RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, and macular thickness.

The Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series is a software analysis module that is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma. It is also intended to compare change over time and determine if statistically significant change has occurred. The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software analysis module for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II - i series (HFA II - i) that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma.

The Carl Zeiss Meditec, Inc. Guided Progression Analysis (GPA) is a software package for the Humphrey Field Analyzer II and II - i series that is designed to help practitioners identify progressive visual field loss in glaucoma patients. GPA compares the visual field test results of up to 14 follow-up tests to an established baseline over time and determines if there is statistically significant change. The GPA printout highlights any changes from baseline that represent larger than expected clinical variability, and it provides simple plain-language messages such as "Possible Progression" or "Likely Progression" whenever changes show consistent and statistically significant loss. The GPA printout also presents the Visual Field Index (VFI), a global index which reports a measure of the patient's remaining useful vision in the form of a percentage, as well as the VFI Rate of Progression plot which provides a trend analysis of the patient's overall visual field history and indicates a 3-5 year projection of the VFI regression line if the current trend continued.

The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy.

The GDxPRO is a confocal scanning laser ophthalmoscope comprising an optomechanical scanning laser head unit and a computer. The device employs Scanning Laser Polarimetry (SLP) to measure the Retinal Nerve Fiber Layer (RNFL) thickness using polarized light.