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The MICROspecialties, keratome blades are designed to produce a corneal flap when used with the following Moria microkeratomes: - MICROspecialties 200200 Blade for use on Moria LSK Microkeratome . - MICROspecialties 600600 Blade for use on Moria CB Microkeratome

The disposable 200200 microkeratome blade is designed to be used with the Moria LSK microkeratome system. The disposable 600600 microkeratome blade is designed to be used with the Moria CB microkeratome system. Both of these blades are designed to produce a corneal flap. The blades are packaged in plastic cases to protect the cutting edge and the placed in a Tyvek/poly pouch. They are sold as ten blades per box or in larger quantities of thirty (three ten-packs). Labeling identifies each quantity per box. The blades are then gamma radiation sterilized. The blades are made from medical grade stainless steel with a single cutting edge. They are assembled with their compatible head and driver systems.

The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer's keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.

The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit. Both blades are packages in a plastic "clamshell" for protection and then double pouched. Each blade will be sold in single units.

The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other manufacture's keratome. These blades are for use in the Insight Technologies Instruments, Model K-SERIES Keratome.

This summary of 510K safety and effectiveness information is being submitted for the MICROspecialties Disposable Keratome Blades with Holder, which an equivalence determination could be based. There are three blade styles as part of this submission, which have very slight differences in blade depth dimension. All of the blades are designed to fit Insight Technologies Instruments keratomes. The blades are manufactured out of the same materials, packaged and sterilized using the same methods. Blades without holders are assembled to keratome drivers with reusable holders. Blades with holders that are being submitted have the holder assembled to the blade thereby making the assembly of the keratome system easier and more convenient. The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns. The holders of these blades will be color coded as a means of additional identification to the labeling. The keratome blades with holders are single-use, disposable. Both blades are packages in a foam case for protection and then pouched. Each blade will be sold in single units.