Search Results
Found 2 results
510(k) Data Aggregation
K Number
K141851Device Name
NAVILAS LASER SYSTEM
Manufacturer
OD -OS GMBH
Date Cleared
2015-01-02
(177 days)
Product Code
GEX, HGF, HKI, NFF, NFG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OD -OS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are 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), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
· For the imaging (capture, display, storage and manipulation) of the eve, including via color. fluorescein angiography 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.
Device Description
The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods, providing the doctor with a system for image capture, display, storage and manipulation for treatment planning and documentation.
The primary components of the Navilas Laser System include:
- . One of three optional ophthalmic laser sources:
- a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
- an optically-pumped semiconductor laser source that also operates at the same -532nm, or
- an optically-pumped semiconductor laser source that operates at 577nm -
- An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,
- A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).
Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).
Ask a Question
K Number
K091064Device Name
NAVILAS LASER SYSTEM
Manufacturer
OD -OS GMBH
Date Cleared
2009-10-27
(196 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
OD -OS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
Device Description
The NAVILAS Laser System is a retinal laser photocoagulator with an integrated digital fundus camera. The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.
The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.
Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.
Ask a Question
Page 1 of 1