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The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging.

The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• Proliferative and non-proliferative diabetic retinopathy
• Macular edema
• Choroidal neovascularization associated with wet age-related macular degeneration
• Age-related macular degeneration
• Central and branch retinal vein occlusion
• Lattice degeneration
• Retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including:

• Iridotomy
• Iridoplasty
• Trabeculoplasty

The Navilas Laser System 577SL is a laser photocoagulator with an integrated digital fundus camera. The Navilas Laser System 577SL combines imaging technologies (color and infra-red imaging) with established laser photocoagulation treatment methods by providing the physician a system for imaging and treatment planning prior to the photocoagulation procedure.

The Navilas Laser System 577SL is comprised of:

• A semiconductor laser source that operates at 577nm wavelength. The laser can operate with Continuous Wave (CW) or Micro-Second Pulsing (MSP).
• An integrated delivery system that directs the laser beam through an ophthalmoscope using motorized mirrors.
• A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
• A software platform that is based on an embedded Windows operating system, that controls the startup, use, calibration, monitoring, and shutdown of the system.

The Navilas Laser System 577SL supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:

Digital imaging - Provided by a color image with white light, supporting mydriatic and nonmydriatic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored, exported or discarded after viewing on the touch sensitive digital display.

Image Storage - Captured images can be digitally stored in the Navilas Laser System 577SL database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.

Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.

Laser Treatment - Treatment options are also unchanged from the predicate device with Pre-planned and Ad-hoc Modes available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.

Report generation - Information collected in the database includes images obtained before, during and after treatment. This information can be used for the generation of patient reports for documentation purposes.

The Navilas Laser System 577SL can emit a 577 nm wavelength beam for photocoagulation with power up to 1700 mW and pulse duration up to 4000 ms.

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