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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.