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510(k) Data Aggregation

    K Number
    K220263
    Device Name
    Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
    Manufacturer
    Vortex Surgical Inc
    Date Cleared
    2022-11-03

    (276 days)

    Product Code
    HQB, HOB
    Regulation Number
    886.4690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vortex Surgical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.
    Device Description
    Vortex Surgical Illuminated Laser Probe is a sterile, single used for delivering laser endophotocoagulation with illumination into the posterior segment of the eye. Vortex Surgical Laser Probe is a sterile, single use medical device used for delivery laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made fiberoptic, one laser connector, one handle for surgeon manipulation, nitinol, PEEK, or stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. The MAXReach model device also contains a slide button allowing the surgeon to bend the nitinol, PEEK, or stainless steel tubing once inside the eye to direct output into the periphery of the eye. On the proximal end the fiberoptic is terminated by a connector that attaches to the distal side, the fiberoptic is terminated by nitinol, PEEK, or stainless steel tubing which penetrates the eye. The probe can be either 23ga, 25ga, or 27ga. The fiber for laser transmission is made from silica glass and is restricted for use with the wavelength of 500nm to 1100mm. In illuminated laser probes, the illumination fiber is made of PMMA. The total length of the device is 90 ± 6 inches. Vortex Surgical Endoilluminator and Chandelier are sterile, single use medical devices used for delivering illumination into the posterior segment of the eye. The endoilluminator is an illuminators made from one fiber optic cable, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and the protective sheath over the fiber. On the proximal side the fiberoptic is terminated by a connector that attaches to the illumination console. The endoilluminator utilizes a needle. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches. The chandelier is an illuminator made from one fiber optic cable and the protective sheath over the fiber. The illumination fiber is made of PMMA. The total length of the devices is 90 ± 6 inches.
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    K Number
    K191846
    Device Name
    MAXReach Laser Probe
    Manufacturer
    Vortex Surgical Inc.
    Date Cleared
    2019-12-23

    (166 days)

    Product Code
    HQB
    Regulation Number
    886.4690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vortex Surgical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
    Device Description
    MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.
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