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510(k) Data Aggregation

    K Number
    K243503
    Device Name
    VIA360™ Surgical System
    Manufacturer
    New World Medical, Inc.
    Date Cleared
    2025-02-14

    (94 days)

    Product Code
    MRH, HMZ
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
    Device Description
    The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.
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    K Number
    K232214
    Device Name
    OMNI Surgical System
    Manufacturer
    Sight Sciences Inc.,
    Date Cleared
    2023-08-25

    (30 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
    Device Description
    The Sight Sciences OMNI Surgical System is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD"). The OMNI device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. A single advancement wheel is located on each side of the handle. This allows the OMNI device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.
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    K Number
    K213173
    Device Name
    TrabEx Pro
    Manufacturer
    MicroSurgical Technologies Inc
    Date Cleared
    2022-06-08

    (253 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
    Device Description
    The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
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    K Number
    K212797
    Device Name
    iPrime Viscodelivery System
    Manufacturer
    Glaukos
    Date Cleared
    2022-01-06

    (126 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery.
    Device Description
    The iPRIMET™ Viscodelivery System is a sterile, single-use ophthalmic surgical instrument for dispensing cohesive viscoelastic fluid (supplied separately, at point of use) during ophthalmic surgery. The iPRIMET™ Viscodelivery System is a delivery device for delivering viscoelastic fluid. The procedure is performed by a trained ophthalmic professional in a sterile surgical setting. The iPRIME device is filled by the user, at the point of use, with FDA approved commercially available cohesive viscoelastic fluid (e.g. HEALON® PRO, Amvisc® or PROVISC®; sold and supplied separately). The iPRIME device consists of a handpiece which includes a reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter manufactured from medical grade materials. The slide button allows the user to adjust the microcatheter length. The dispense trigger dispenses the viscoelastic fluid. The rotatable hub allows the user to adjust the angle of the cannula in order to dispense viscoelastic fluid into other areas within the anterior chamber. The iPRIMET™ Viscodelivery System serves as dispensary means to deliver cohesive viscoelastic fluid. The OVD device containing the viscoelastic fluid is connected to the iPRIME luer fitting and viscoelastic is pumped into the iPRIME device. After the device is fully primed and the microcatheter has been extended to the desired location, the user advances forward the dispense trigger delivering a small amount of viscoelastic fluid into the desired location within the anterior chamber of the eye.
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    K Number
    K211680
    Device Name
    Streamline Surgical System
    Manufacturer
    New World Medical, Inc.
    Date Cleared
    2021-10-08

    (129 days)

    Product Code
    MRH, HMX
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery. The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.
    Device Description
    The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid. The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision. The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification. The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device. The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2). The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use. Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.
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    K Number
    K202678
    Device Name
    OMNI Surgical System
    Manufacturer
    Sight Sciences, Inc.
    Date Cleared
    2021-03-01

    (167 days)

    Product Code
    MRH, HMZ
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
    Device Description
    The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD"). The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below. Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles). Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.
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    K Number
    K201953
    Device Name
    OMNI PLUS Surgical System
    Manufacturer
    Sight Sciences, Inc.
    Date Cleared
    2020-08-11

    (28 days)

    Product Code
    MRH, HMZ
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNI® PLUS Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated.
    Device Description
    The OMNI PLUS Surgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic fluid into the anterior segment of the eye during ophthalmic surgery and cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI PLUS device is provided sterile and disposed after singlepatient use. The device is fabricated from biocompatible materials standard to the medical device industry. The OMNI PLUS Surgical System dispenses fluid on the principle of exchanging volumes much like a syringe and are designed to function with commercially available cohesive viscoelastic fluids (also known as an ophthalmic viscosurgical device, or "OVD") that are commercially available from companies such as Johnson & Johnson, Bausch & Lomb, and Alcon. The OMNI PLUS device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI PLUS device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating either advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles. When the OMNI PLUS device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes a plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid as the microcatheter is being retracted back into the stainless-steel cannula. When the OMNI PLUS Surgical System is used to perform a trabeculotomy procedure, the beveled tip of the curved stainless-steel cannula is used to enter Schlemm's canal through the trabecular meshwork. The polymeric microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere. The OMNI PLUS Surgical System is an additional model based on the current OMNI Surgical System design; OMNI PLUS is designed to dispense a nominal volume of 21 microliters of viscoelastic fluid.
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    K Number
    K173332
    Device Name
    OMNI Surgical System
    Manufacturer
    Sight Sciences, Inc.
    Date Cleared
    2017-12-21

    (59 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
    Device Description
    The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid.
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    K Number
    K171905
    Device Name
    VISCO 360 Viscosurgical System
    Manufacturer
    Sight Sciences, Inc.
    Date Cleared
    2017-07-27

    (31 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic surgery.
    Device Description
    The Sight Sciences VISCO360 Viscosurgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The VISCO360 is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (OD or OS) using either hand.
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    K Number
    K143205
    Device Name
    Viscoelastic Injector
    Manufacturer
    Sight Sciences, Inc.
    Date Cleared
    2014-12-05

    (28 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    MRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.
    Device Description
    The Sight Sciences Viscoelastic Injector is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The Viscoelastic Injector is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The Sight Sciences Viscoelastic Injector dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, injection tube, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (00 or OS) using either hand.
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