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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 BD K-4000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as Laser In-situ Keratomileuses (LASIK) surgery.

The BD K-4000™ Microkeratome System is a battery operated, fully automated Keratome. The Microkeratome is a precise cutting device uniquely designed for added comfort, speed and accuracy. The Microkeratome's unique shape is designed to offer more comfort and efficiency while delivering precision and accuracy. The BD K-4000™ Microkeratome major components are: - Console containing the motor drive and control circuitry, Vacuum system and battery power source - Front Panel controls for operating the system; - Surgical Handpiece connected to the console by multi-conductor cable - Vacuum tubing set: - Two pedal Footswitch for actuation of the handpiece and vacuum system; - External Battery Charger.

The BD K-3000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as in Laser In-situ Keratomileuses (LASIK) surgery. The corneal resection is consistently of a predetermined diameter, thickness and uniform surface quality for precise lamellar cuts and consistent flap generation.

The BD K-3000™ Microkeratome System is a battery operated, fully automated Keratome device to produce a corneal resection prior to laser ablation l laser applications and procedures such as, in Laser In-situ Keratomileusus K) surgery. The Microkeratome is a precise cutting device uniquely designed for comfort, speed and accuracy. The BD K-3000™ Microkeratome System enables ons to cut precision flaps quickly and easily. The Microkeratome's unique shape is ned to offer more comfort and efficiency while delivering precision and accuracy. e Microkeratome system features: - One-piece fully assembled handpiece allows complete assembly prior to positioning on the eve - he handpiece is ergonomically designed and of titanium construction to increase rgeon comfort - components are fully interchangeable for flexibility - keratome system consistently produces a corneal resection of a predetermined er, thickness and uniform surface quality. - ratome head assures depth consistency. The head houses a precision blade elivers constant drive alignment through a double dovetail suction ri - keratome handpiece contains dual motors. One controls oscillation of the e and a second translates the head across the eve. - teratome handpiece automatically returns to home position without oscillating.

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

Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.

Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.

The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

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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.

The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.