Search Filters

Search Results

Found 4 results

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?
    Product Code :

    MLZ

    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.
    Ask a Question
    K Number
    K170520
    Device Name
    HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
    Manufacturer
    Alcon Research, Ltd.
    Date Cleared
    2017-03-22

    (28 days)

    Product Code
    MLZ
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HyperVit™ Vitrectomy Probe (23, 25 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye. HyperVit™ Vitrectomy Probe (27 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows: - Vitreous aspiration & cutting - Membrane cutting & aspiration - Lens removal - Dissect tissue in the eye
    Device Description
    The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge. The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.
    Ask a Question
    K Number
    K093305
    Device Name
    ENHANCED ULTRA VIT PROBE
    Manufacturer
    ALCON RESEARCH, LTD.
    Date Cleared
    2010-04-02

    (162 days)

    Product Code
    MLZ
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALCON® Enhanced UltraVit® Probe is indicated to be used to remove vitreous and dissect tissues in the eye.
    Device Description
    The ALCON Enhanced UltraVit® Probe is a modified vitrectomy probe that will be added to the existing Alcon UltraVit® probe family. The ALCON Enhanced UltraVit® Probe is the same size and shape as existing Alcon vitrectomy probes and is made with the same material as the Alcon UltraVit® probes used on the CONSTELLATION® System (Alcon Vision System, K063583). The ALCON Enhanced UltraVit® Probe will utilize existing packaging configurations and have the same shelf life as existing vitrectomy probes. It will be used with the CONSTELLATION® System. The differences between the enhanced and predicate versions are: - Increased maximum cut rate. . - . Software look-up table changes to accommodate RFID recognition of new probe. - Parylene N Coating on "O" ring seals. .
    Ask a Question
    K Number
    K081681
    Device Name
    VITRECTOMY CUTTER AND ACCESSORIES
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Date Cleared
    2008-10-08

    (113 days)

    Product Code
    MLZ
    Regulation Number
    886.4150
    Why did this record match?
    Product Code :

    MLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.
    Device Description
    The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.
    Ask a Question

    Page 1 of 1