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The ONE UP disposable keratome head is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

The ONE UP disposable keratome head and suction ring are identical in design, concept and principle to the predicate PLANCON microlamellar keratome single piece head K 970 377, the only difference being that the keratome head, the ring and the handle are made of high density plastic material. The stainless steel blade and the plastic blade holder are similar to the blade and blade holder of the above predicate. The keratome head has dovetails guides which engage in the dovetails of the suction ring. The blade oscillates by means of the same turbine of the predicate device referred above. The power unit is similar in characteristics, principles and functions to the power units of legally marketed keratomes. The ONE UP disposable keratome head comes preassembled and presterilized in a copolyester sealed tray, sealed with TYVEK ® peel off cover. The sterilisation is performed under validated gamma radiation cycle with sterility assurance level of 10 ° and dosimetric release. The plastic materials used for patient contact portion of device have been tested according to classification of USP and the grades used passes classes I through VI, and are deemed to be biocompatible.

The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

The CARRIAZO BARRAQUER microkeratome system composition includes: a) Power unit, b) Keratome head, c) Keratome blade, d) Motor, e) Footswitches, f) Applanator lenses, g) Suction rings. The power unit includes pumps for producing vacuum and can operate the keratome by means of a 12 V DC motor or by means of a nitrogen motor. The keratome head adapts to the turbine or to the motor and includes the blade. Different heads are available to adjust the thickness of the cut. The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome. The applanator lenses are made of clear methylmethacrylate with a stainless steel handle and are used with the rings to control disk diameter before the cut.