This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

This database entry covers UDI for SW Versions 1.4.1 and higher: (01)04049471000037(10)150-> Version 1.5

Single use patient interface for the VisuMax laser keratome

single use patient interface for VisuMax laser keratome

single use patient interface for VisuMax laser keratome

single use patient interface for VisuMax laser keratome

The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.).This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420

This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplace): (01)04049471070101(10)310 -> Version 3.1, (01)04049471070101(10)311 -> Version 3.1.1, (01)04049471070101(10)350 -> Version 3.5

Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6

floor stand

ceiling mount

he AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.

The CIRRUS photo 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 nonmydriatic 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 anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.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. The CIRRUS photo 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 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 nonmydriatic 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 anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc.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. The CIRRUS photo 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 FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally.

The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:• Lens thickness• Corneal curvature and thickness• Axial length• Anterior chamber depth• Pupil diameter• White-to-white distance (WTW)For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D- naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.

QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. The device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation and anterior vitrectomy.

The SL 115 Classic Slit Lamp is a AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment. The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

The SL 120 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

The SL 130 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.

The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.

The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:* Proliferative and nonproliferative diabetic retinopathy* Macular edema* Branch and central retinal vein occlusion* Lattice degeneration* Retinal tears and detachments

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.The DI number characterizes the laser console which has a dual fiber port. The laser console with dual fiber port forms part of both models, VISULAS green classic and VISULAS green comfort.

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.The DI number characterizes the laser console which has one single fiber port. The laser console with single fiber port forms part of both models, VISULAS green classic and VISULAS green comfort.

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.The DI number characterizes the laser slit lamp LSL green comfort. This laser slit lamp forms part of the model VISULAS green comfort.

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.The DI number characterizes the laser slit lamp LSL green classic. This laser slit lamp forms part of the model VISULAS green classic.

The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as:* Photocoagulation of the retina* Trabeculoplasty for treatment of glaucoma* Iridotomy for treatment of glaucoma.The VISULAS Trion Laser System with the VITE option is intended for use in multispot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:* Proliferative and nonproliferative diabetic retinopathy* Macular edema* Branch and central retinal vein occlusion* Lattice degeneration* Retinal tears and detachments* Choroidal neovascularization associated with wet age-related macular degeneration.

This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses whichare guided through the aperture in the treatment objective .The optical system focuses the laser beam into the corneal tissue.The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty• In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting• Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.Additionally under class III: The VisuMax Femtosecond Laser is indicated for use in small incisionlenticule extraction (SMILE) for the reduction or elimination ofmyopia with or without astigmatism• for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters,• for cylinder from -0.75 diopters through -3.00 diopters,• when refraction spherical equivalent is no greater in magnitude than 10.00 diopters,in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.

The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented.