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510(k) Data Aggregation

    K Number
    K220030
    Device Name
    Vista Ophthalmics Vitrectomy Probe
    Manufacturer
    Vista Ophthalmics LLC
    Date Cleared
    2022-05-04

    (119 days)

    Product Code
    MLZ
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vista Ophthalmics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista Ophthalmics vitrectomy probe is intended to be used to remove vitreous and dissect tissue in the eye as follows: · Vitreous aspiration & cutting · Membrane cutting & aspiration · Lens removal · Dissect tissue in the eye The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.
    Device Description
    The Vista vitrectomy probe is a pneumatically actuated device which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during anterior and posterior ophthalmic procedures. The Vista vitrectomy probe is offered in a two port bi-blade configuration. The Vista vitrectomy probe utilizes a pressured air pulse to drive the cutting action. The pressure pulse originates from the operational system of choice and distends or expands a silicone rubber diaphragm inside the handpiece. The pressure pulse fills the pressure chamber of the vitrector, actuating the axial extension of the inner-cutting tube to produce a guillotine-type cutting motion. A vacuum originating from the operational system of choice draws biological materials (tissue and fluid) into the outer cutting port area of the cannula that is inserted into the patient's eye. The vacuum-drawn material entering the outer needle port is then resected by the inner-cutter as it travels down the inside diameter of the outer needle. Once the inner-cutter resects (guillotines) the material as it crosses the distal end of the outer needle port cutting edge, the material is aspirated through the inside diameter of the inner-cutting tube. The material continues to be aspirated through the handpiece and into a collection chamber of the vitrectomy system selected for use with the Vista vitrectomy accessory.
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