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The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy. Faros is used for these surgical interventions in the anterior eye segment: - Irrigation and aspiration (I/Afunction) - Ultrasound phaco (PHACO function) - Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function) - Bipolar diathermic capsulotomy (CAPS function) - Operation of a vitrectomy instrument (VIT function) The device may only be used with the instruments recommended and supplied by Oertli.

The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery. The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.

UNITY VCS: The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. UNITY CS: The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device. When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting. The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation. The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network. Both devices are for prescription use only.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052. A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168). The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience. The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017. This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM. The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The Centurion™ Vision System (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal. The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF. SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Alcon's CENTURION™ Vision System is an ophthalmic surgical instrument designed to provide cataract extraction using the CENTURION™ OZil™handpiece, the CENTURION™ Active Sentry™ handpiece, and the INFINITI™ OZil™ handpiece. The CENTURION™ Vision System is intended for use in small incision cataract extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the eye, while replacing aspirated fluid and lens material with balanced salt solution (BSS™). This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration vacuum, and the flow of BSS™ irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy. This device is for Prescription Use (Rx) only.

QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation. QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values. QUATERA 700 has the following functions: - · Irrigation and Aspiration - · Ultrasound Capability - · Diathermy - · Anterior Vitrectomy - Reflux QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

The intended use of the MICOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic subretinal microinjection of gases or aqueous fluids. In addition, the optional laser is indicated for the following: | Condition | Treatment | |-------------------------------------------------------------------------------|----------------------------------| | Diabetic Retinopathy | | | • Proliferative Diabetic Retinopathy | • Panretinal Photocoagulation | | • Clinically Significant Macular Edema | • Focal or Grid Laser | | Retinal Tear and Detachments | Laser Retinopathy | | Lattice Degeneration | Retinal Photocoagulation | | Sub-retinal (choroidal) Neovascularization | Focal Laser | | Retinal Vascular Occlusion | | | • Neovascularization secondary to Brand or Central retinal vein occlusion | • Scatter Laser Photocoagulation | | • Chronic macular edema secondary to Branch or Central retinal vein occlusion | • Focal or Grid Laser | | Glaucoma | | | • Primary Open-angle | • Trabeculoplasty | | • Closed Angle | • Iridotomy or Iridoplasty |

The EVA NEXUS™ Ophthalmic Surgical System (EVA NEXUS) is a combined anterior and posterior procedure ophthalmic system that is modular in design and is identical in most respects to the recently cleared predicate EVA Ophthalmic Surgical System (K190875). EVA NEXUS (see Figures 1, and 2 for external views) is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.