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The Tomey Corneal Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicrosopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Corneal Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.

The Tomey Cornea/Anterior Segment OCT CASIA2 (CASIA2) is a non-contact, high resolution tomographic and biomicrocopic device indicated for in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings. CASIA2 consists of several components: the main unit, AC input power source, a touch panel LCD monitor, an external hard drive (HDD), a mouse and a keyboard. CASIA2 is an anterior segment OCT that obtains images by A-scanning with swept-source OCT. OCT images are created by the intensity of the light (backscattered light) that returns in the same path as that of incident light among the scattered light of each tissue. Thus, it is created with higher intensity in the tissues that generate strong backward scattering.

The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory. Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.

The NON-CONTACT TONOMETER FT-1000 is indicated for the measurement of intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The NON-CONTACT TONOMETER FT-1000 is a tonometer designed using a non-contact measurement system. Air puff gently measures the intraocular pressure of the human eye.

The Tomey "ConfoScan" Confocal Microscope is intended for use in carrying out a visualization of the cell layers of the anterior parts of the eye. The Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye.

The Tomey "ConfoScan" Confocal Microscope is a scanning slit microscope system that is used to carry out a visualization of the cell layers of the anterior parts of the eye. The prime attributes of a Confocal Microscope include both improved contrast and spatial resolution over more conventional microscopy. The improved image rendition is accomplished in the Tomey "ConfoScan" Confocal Microscope by the introduction conjugate scanning slits into the viewing and illuminating light paths of the microscope. By illuminating and viewing an object through restricted apertures, it is possible to eliminate the contributions of scattered light from other regions in the object plane that can degrade contrast and spatial resolution.

The ImageScape is intended to be used to capture, store and manipulate digital images of the retina taken by fundus camera. The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.

The ImageScape consists of: (1) a digital camera; (2) an imaging board; (3) a personal computer; (4) a monitor; and (5) Tomey's Windows-based image processing software. The ImageScape is used during ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp with a fundus camera. Images are transferred to the ImageScape's imaging board, located in the ImageScape's personal computer, and stored in the computer's Random Access memory ("RAM") and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to operate the icons.

The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment. There are no differences with respect to the predicate devices for indications for use, or target population.

Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.