NAVILAS Laser System

The Navilas Laser System 577s is indicated for use:

- In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).

- For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.

- In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

The Navilas Laser System 577s is indicated for use: - In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy). - For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye. - In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

The Navilas Laser 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas 577s Laser System combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation. The Navilas Laser 577s is comprised of: A semiconductor laser source that operates at 577nm. The semiconductor laser source for the Navilas 577s is identical to the laser source used with the Navilas 577+ cleared under K141851. 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 intended to be used to capture display, store and manipulate images captured by the fundus camera. The Navilas Laser System 577s supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including: Digital imaging as provided by a color image with white light, supporting mydratic and non-mydratic 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 or discarded after viewing on the touch sensitive digital display. Image Storage - Captured images can be digitally stored in the Navilas Laser System 577s 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.