HAI EB-2000xyz is the non-contact eyebank specular microscope which is to be used to evaluate the endothelial cells layer for layer for both human and animal cornea.HAI EB-2000xyz used the same design as the Bio-Optic Inc. (An US manufacturer), it considered the device substantially equivalent to legally marketed predicate devices market predicate devices market in interstate commerce prior to May 28, 1976. That do not require approval of a premarket approval. According to the letter from FDA on April. 26, 2094.
An electrically-powered, ophthalmic, binocular microscope designed for in vivo examination of the inner cellular lining of the cornea (endothelium), and to capture and analyse endothelial cell images, typically to assist with the diagnosis of various corneal disorders (e.g., corneal dystrophies, degenerative diseases, pre- and post-operative assessment). It is typically a desk-top unit with a patient head rest and dedicated software.