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To measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle to-angle width and sulcus-to-sulcus width. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the method by which the arc-scanning motion is achieved. The materials from which the patient-contact portions of the device are made are the same as in the predicate device. The acoustic output of this device is similar to that of predicate devices and well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."