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The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

List of components - Power unit and footswitch . - Handpiece / submitted device motor . - Head and blade separator . - Suction rings . a) Power unit and footswitch The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) already legally marketed in the USA by our company. The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor. The front panel includes several displays and features: - . Vacuum pressure gauge, Battery level indicator, - . Battery charge indicator, - Connector for the motorized handpiece of the submitted device . - Vacuum outlet connector . The back panel includes connectors for footswitches and battery charger b) Handpiece / submitted device motor The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea). c) Head and blade separator The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts: - > The metal part in low carbon steel, and - > The plastic holder of the blade separator, which is not in contact with the patient's eye. d) Suction rings The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions: - > Reusable - > Disposable

The M3 microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

List of components - Power unit . - Motor ● - Suction rings . - Applanator lenses . - Footswitches . - Keratome head 1 - Keratome blade .

The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.

List of components - Power unit - Motor - Suction rings - Applanator lenses - Footswitches - Keratome head - Keratome blade a) Power unit The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & CARRIAZO BARRAQUER II Microkeratome (K002191) already legally marketed in the USA by our company. The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor. Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel. The front panel has several displays and features: - Vacuum pressure gauge, - Gas pressure gauge, - Battery level indicator, - Battery charge indicator, - Connectors: DC motors outlets, Gas turbine outlet Gas outlet, Vacuum outlet The back panel has several displays and features: - Connectors: Gas inlet, Foot pedals, - Battery charger. All connectors are of different types for preventing connection mistakes. b) Keratome motor The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome). c) Keratome head In the keratome head, a blade activated by an oscillation motor is inserted. Different heads are available in order to adjust the thickness of the cut. d) Suction rings The suction rings are used to fixate and pressurize the eye and to provide a base for the microkeratome heads. e) Applanator lenses The applanator lenses are made of clear methylmethacrylate with a stainless steel handle. They are used with the rings to check disk diameter before the cut. The upper part is convex for magnification. The base part (contact part) is plane, with an engraved and calibrated reticule diameter. f) Keratome blade The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye. Different blades are available in order to adjust the thickness of the cut.

The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

List of components a) Power unit b) Motor c) Suction rings d) Applanator lenses e) Footswitches f) Keratome head with pre-inserted Keratome blade