Search Results

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.

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.

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

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.

VitreQ Disposable Laser Probes, 90° Directional Laser Probes and 90° Directional Illuminated Laser Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments at operating wavelengths of 500nm to 900nm. The 90° Directional Illuminated Laser Probes, Light Fibers and Chandelier are for illumination during ophthalmic surgery and should only be used with the light wavelength range of 425nm to 700mm.

The VitreQ Disposable Laser Probe is an ophthalmic instrument, which is used in posterior segment eye surgery and is appropriate for photocoagulation. The device can be connected to an ophthalmic laser generator, which is not a part of this application. The VitreQ Disposable Laser Probe is introduced into the posterior segment of the eye through an incision or an ophthalmic entry port, after the vitreous is removed during vitreoretinal surgery. The Disposable Laser Probe guides the laser energy to the intended surgical site to provide photocoagulation treatment. The laser enerqy intensity or power output is not controlled, altered or significantly reduced by the disposable laser probe. The laser spot size on the target tissue can be varied by altering the distance between the tissue and the probe tip. To reach the target tissue in the periphery section of the 90° Directional Laser Probe tip can be directed due to bending the metal tip. The angle of the tip in the most directed position is about 90°. An angled laser probe reduces the need of a strong indentation of the eye and is intended to prevent accidently touching the crystal lens. The VitreQ Disposable Laser Probes, 90° Directional Laser Probes and (90°) Directional Illuminated Laser Probes are constructed with an optical laser connector, a glass fiber optic covered by a protective sheath and one handle for surgeon manipulation, metal tubing is extending from the handle which penetrates the surgical site. The device is intended for singleuse only. The VitreQ Disposable Laser Probes can only be used with a medical laser at an operating wavelength range of 500nm to 900nm. For the VitreQ Disposable Laser Probes, (90°) Directional Illuminated Laser Probe the functionality is combined with illumination. To achieve the illumination of the surgical site, the probe is constructed with an additional plastic fiber, which has a connector to attach the fiber to an ophthalmic light source, which is not a part of this application. The VitreQ Disposable Light Fibers are constructed with a handle, the plastic illumination fiber, and the connector to attach the fiber to an ophthalmic light source. To match the connection to the ophthalmic light source, there are several reusable light source adaptors available. The VitreQ (90°) Directional Illuminated Laser Probes, Light Fibers and Chandelier can only be used with the light wavelength range of 425nm to 700nm.

For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources. The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm. The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device. The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.

For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources. The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

The Synergetics Disposable Directional Endo Ocular Laser Probe provides a mean for delivering endophotocoagulation during vitrectomy surgery.

The Synergetics™ Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthalmic laser delivery device. The Laser Probe assembly includes a probe tip (distal end), a handpiece and a coupling means (proximal end) for connecting the Laser Probe to a commercially available laser source. Glass optic fiber protected by PVC tubing is provided between the handpiece and the coupling means. The probe tip, handpiece, tubing and coupling include a passageway for an optic fiber to transmit laser energy from the proximal end through the assembly to the distal end of the probe tip includes a rounded circumferential edge and smooth distal end surface to minimize tearing or snagging of tissue during insertion of the probe assembly through an incision at the sclera at pars plana. The laser fibers work on the principle of total reflection. Laser energy is focused into the glass silica fiber at the proximal end of the probe and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser through the proximal end through the assembly to the distal end of the laser probe.

The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses: 27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.) 27+ Flex-Tip Laser Probe: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.) 27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System) 27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae) 27+ Infusion Cannula: Posterior segment infusion (liquid or gas)

The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.

The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.