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510(k) Data Aggregation

    K Number
    K983317
    Device Name
    BARRON MICROKERATOME SYSTEM, MODEL B2000
    Date Cleared
    1998-12-02

    (72 days)

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

    BARRON PRECISION INSTRUMENTS, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Barron Microkeratome System is indicated for performing lamellar sectioning of the cornea.
    Device Description
    The Barron Microkeratome System consists of two components: a single-use Microkeratome and a Control Console that provides 9V DC and vacuum to the Microkeratome. The Barron Microkeratome is designed to perform a lamellar section of the cornea to vield a flap of predetermined diameter, thickness, and flap hinge width. The product will be offered in various sizes to provide flap diameters from 7.5 mm to 10.5 mm, and flap thickness of 130 um, and 180 um. The lamellar section is obtained by an oscillating stainless steel blade that is driven by a small motor in the Microkeratome. The Microkeratome is fixated on the eye by use of vacuum which is applied to a Vacuum Ring that seats on the eye. The vacuum exhaust from the Microkeratome is isolated from the ambient atmosphere by a 0.45-um hydrophobic filter. The Microkeratome is supplied in a sterile package, and includes all components that are necessary to perform the section. The package contains the fully assembled and inspected Microkeratome including Vacuum Ring, Luer Lok connector with filter, Vacuum Tubing, Blade, Electrical wire, and Electrical connector. There are no reusable components to be sterilized, and there are no reusable motor and drive mechanisms that are subject to long term wear. The entire Microkeratome, including the motor and the blade drive mechanism, are disposable. The only reusable portion of the Barron Microkeratome is the electronic Control Console, which is outside the operative sterile field.
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