Device Description : The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and (View more) 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. (View less)

Device Description : The VISUPAC digital image capturing and archiving system is intended for capturi (View more) 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. (View less)

Device Description : The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra- (View more) 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. (View less)

Device Description : The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopi (View more) 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. (View less)

Device Description : The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopi (View more) 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. (View less)

Device Description : An AC-powered slit lamp biomicroscope is intended for use in eye examination of (View more) 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. (View less)

Device Description : This database entry covers UDI for SW Versions 1.4.1 and higher: (01)04049471000 (View more) This database entry covers UDI for SW Versions 1.4.1 and higher: (01)04049471000037(10)150-> Version 1.5 (View less)

Device Description : Single use patient interface for the VisuMax laser keratome

Device Description : single use patient interface for VisuMax laser keratome