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510(k) Data Aggregation

    K Number
    K231298
    Device Name
    Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
    Date Cleared
    2023-10-31

    (180 days)

    Product Code
    Regulation Number
    878.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alesi Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
    Device Description
    The Integrated Monopolar L-Hook (H/S)™ is a bifunctional device that combines proprietary visual field clearing and monopolar HF tissue and coagulation in a single device. The Integrated Monopolar L-Hook (H/S)™ can only interface with the Ultravision2 generator which connects directly to a commercially available electrosurgical generator (ESU) for its HF monopolar energy source. The Integrated Monopolar L-Hook (H/S)™ provides two recessed smoke clearing emitters that are automatically activated to clear the visual field when the device cutting function (HF) is activated. The mode of action of visual field clearing is electrostation as per the predicate Ultravision system. When the tissue cutting is ceased, the visual field clearing signal is automatically switched off after a short delay period that is settable on the Ultravision 2 generator user interface. Activation of the HF function of the Integrated Monopolar L-Hook (H/S)™ is via a yellow (Cut) or blue (Coag) button located on the handpiece, or via a footswitch if this connected to the parent electrosurgical generator which is connected to the Ultravision 2 system. The Integrated Monopolar L-Hook (H/S)™ itself is incompatible with the connectors of third party electrosurgical generators. On demand visual field clearing only can also be applied by activation of a third grey button on the handle. This clearing field action is stopped immediately after release of the grey button. The Integrated Monopolar L-Hook (H/S)™ is available with of 32cm. It is intended to be introduced via standard 5mm surgical trocars as long as their internal diameter is 5.70mm or greater. The device is for prescription use only.
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    K Number
    K200035
    Device Name
    Ultravision Visual Field Clearing System
    Date Cleared
    2020-05-04

    (117 days)

    Product Code
    Regulation Number
    878.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alesi Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during surgery, including laparoscopic surgery. The Ultravision™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
    Device Description
    The Ultravision™ Visual Clearing System removes surgical smoke and particulates from the visual field by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ultravision 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™M Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.
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    K Number
    K182053
    Device Name
    Ultravision™ Visual Field Clearing System
    Date Cleared
    2018-09-07

    (38 days)

    Product Code
    Regulation Number
    878.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alesi Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The Ultravision™ 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
    Device Description
    The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision™ Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The trocar may be used with or without the Ionwand component of the system. The system is powered using a rechargeable battery or through mains power. Accessories include the rechargeable battery, battery recharging station, mains converter power supply, mains converter, power supply unit, and patient return adaptor.
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    K Number
    K170178
    Device Name
    Ultravision Visual Field Clearing System
    Date Cleared
    2017-05-26

    (127 days)

    Product Code
    Regulation Number
    878.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alesi Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
    Device Description
    The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.
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    K Number
    DEN150022
    Device Name
    Ultravision Visual Clearing System
    Date Cleared
    2016-12-20

    (574 days)

    Product Code
    Regulation Number
    878.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alesi Surgical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
    Device Description
    The Ultravision™ Visual Field Clearing System is a device that precipitates surgical smoke generated during laparoscopic procedures to clear the visual field. The device components are summarized briefly in Table 1, below.
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