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The VisuMax Femtosecond Laser is cleared for the following indications for use: · In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; · In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting; · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.

The VisuMax Femtosecond Laser is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

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

The Evolution 3E Console includes pumps for producing vacuum for use with a keratome in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea. The Evolution 3E Console power unit has been designed to operate the keratome by means of electric motor or turbine.

The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment.

The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure. With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge. The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters. The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechik GmbH. The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium. The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator. The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum. The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.

The Carriazo-Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

The Carriazo-Pendular is an AC powered microkeratome. Cutting head and blade are designed in a convex form similar to the cornea itself. Due to the unique pendulum motion of the Carriazo-Pendular, the cornea becomes more applanated in the center than in the periphery. This technology provides a homogeneous and predictable flap thickness and smooth cutting edges. The Carriazo-Pendular consists of: Carriazo-Pendular console, Cutting heads, Suction rings, Foot switches, Monitoring software.

The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.

The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.

The Horizon Epikeratome™ is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar connections of preselected thickness and diameter and for the separation of the epithelium from the comea for subsequent surgical procedures and thatleter

The device consists of a control console and disposable HORIZON EPIKERATOME™ microkeratome hand pieces. The control console contains a suction pump, electronics, and a flexible cable to actuate the disposable microkeratome. The basic system sold consists of the control unit, disposable microkeratomes (sold sterile) for corneal resection, a special microkeratome for epithelial separation, practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals. The HORIZON EPIKERATOME™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes a separator also made of biocompatible polycarbonate plastic.. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation. The hand ieces for corneal resection use a surgical -grade steel blade instead of a plastic separartor. The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by a flexible mechanical transmission cable. The motors are ULand CE approved. The central unit also supplies the suction. The single cable transmits both the motion to cause the blade (or separator) to oscillate and translate the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: console, separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator. The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.

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 Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190. The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Amadeus II Epikeratome is a modification of the ACCM/Amadeus Microkeratome, which is firmly established in the market for several years. In the course of a product update, the designs of blade and blade holder have been modified to provide surgeons with the option to perform Epi-LASIK. The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical. To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraccular pressure to a level allowing the epikeratorne blade to move across the cornes in a mode similar to that of a carpenter's plane. The corneal flap is made by the same open ating principle as in the predicate device, i.e., a blade is advancing and simultane opelva oscillating horizontally and perpendicular to the advancement direction. A Control Unit provides power and a controlled vacuum for fixing the eye. The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and thre hlade holder. Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components: - a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand. - b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs. - c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action. Disposable components of the Amadeus II Epikeratome system are 1) a sterile plastic epikeratome blade and 2) a sterile vacuum tubing kit. Additionally, an autoclavable instrument tray is provided for sterilization.

The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).