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510(k) Data Aggregation

    K Number
    K052891
    Device Name
    HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
    Manufacturer
    HAWKEN INDUSTRIES
    Date Cleared
    2006-03-23

    (161 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAWKEN INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    Device Description
    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.
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    K Number
    K981155
    Device Name
    FLAPMAKER DISPOSABLE MICROKERATOME
    Manufacturer
    HAWKEN INDUSTRIES
    Date Cleared
    1998-08-14

    (136 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAWKEN INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.
    Device Description
    The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals. The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. 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 microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic. The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to 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.
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