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The UltraShaper™ System is an AC-powered device that is intended to shave a partial lamella section of the cornea.

The UltraShaper™ System consists of the following components: (a) cutting head, (b) suction rings / handles, (c) motor handpiece, (d) handpiece-to-console cable, (e) suction tubing set, (g) blade assembly, and (h) console power / suction supply with foot actuated switches. The cutting head and suction rings / handles are constructed entirely from stainless steel. The UltraShaper™ System is designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor (in the motor handpiece) controlled by foot switch. The cutting head slides on dovetail guides on a circular suction ring. The cutting head contains a gear drive train that engages a gear rack on one side of the suction ring to drive the keratome head across the suction ring and cornea. The suction ring provides an annular vacuum chamber for temporary attachment to the ocular globe. The cutting head has a fixed foot plate and is available in three standard head sizes, 130, 160 and 180 microns, depending on the thickness of the corneal section desired. There are also three different suction ring / handle sizes available to accommodate the variations in corneal curvature from patient to patient. A (motor handpiece-to-console) cable is also supplied with each UltraShaper™ keratome. The UltraShaper™ Console Power Supply provides the power to both the keratome motor and the suction supply for holding the ring in place on the cornea. This is the same console which drives the company's ADK disposable keratome. The console has three vacuum suction settings, HIGH, LOW, OFF. The console will only permit the keratome to operate (transverse the cutting plane) while in the HIGH setting. While in the HIGH mode, the console, with its internal barometer, reacts to vacuum suctions values which are below the optimum by signaling the operator with audible and visual warnings. The UltraShaper™ Console Power Supply conforms to IEC-601-1 electrical safety standard. A sterile suction tubing set, which is generic to several keratome systems, is used to connect the suction ring / handle of the UltraShaper™ to the suction port on the console. Suction tubing sets are supplied sterile and are intended for single use. Likewise, keratome blades are supplied sterile and are intended for single use.

ADK (Automated Disposable Keratome) is intended to perform anterior, lamellar, circular corneal resections of a predetermined diameter and thickness.

The Automated Disposable Keratome consists of two components: (a) disposable keratome, (b) power / suction supply and DC motor with foot actuated switch. The ADK is a keratome designed to perform anterior lamellar circular corneal resections of a predetermined diameter and thickness based upon the principle of a carpenter's plane. A cutting blade emerges from the center of the keratome plane. The stainless steel blade oscillates by a small DC motor controlled by foot switch. The keratome, which is fabricated from high density engineering plastic (except the blade and motor), has a one piece head that is pre-assembled with a fixed foot plate, and is available in two standard head sizes, 130 or 160 microns, depending upon the thickness of corneal section desired. The keratome head has dovetail guides, which correspond to guides on the suction ring that is placed upon the ocular globe. Tandem gears on both sides of the keratome head and corresponding gears on the suction ring automatically move the cutting blade along the dovetail guides. Whereas gears on competitive keratomes are exposed, the gears on the ADK are covered to minimize entrapment of lashes and lids. A DC motor controls the gears and blade movement via the foot switch control. The cutting principle is the same as with manual keratomes and other automated keratomes. The automatic movement of the keratome allows for a more uniform translation across the suction ring and thusly across the cornea. The power supply provides the power to both the keratome motor and the suction supply for holding the suction ring in place on the cornea. The ADK has three settings for vacuum control: "off", "low", "high"; whereas predicate devices have only two vacuum settings, "on" and "off". The vacuum suction of predicate devices in the "on" position is the same as the suction of the "high" setting of the ADK. The "low" suction setting of the ADK provides the option of using the suction ring to aid in globe fixation after the resection. Predicate devices require the surgeon to use the "off" position for globe fixation after resection, where residual suction declines variably back to 0 mmHg. The keratome is provided sterile in a sealed blister/Tyvek® tray and is discarded after single use.