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Furthermore, OD-OS retains the right to change or amend the information on this website.
Copyright
The information on this website is owned or controlled by OD-OS GmbH (OD-OS), Germany. It is protected by copyright laws worldwide. Any reproduction other than downloads for non-commercial purposes, or modification of this website, in whole or in part, is prohibited.
Disclaimer
It is our goal to keep the information on this website as accurate and up to date as possible. However, the information may still contain errors and/or omissions, for which we disclaim any responsibility.
Regulatory status
The Navilas® Laser System 532+, the Navilas® Laser System 577+ and the Navilas® Laser System 577s are CE-marked and 510(k) cleared for use in the US. The products, features and procedures described on this website may not be approved/available in your country yet. Please contact our regional representative and/or OD-OS regarding availability and regulatory status in your country.
Design and specifications
Design and specifications are subject to change without notice as a result of ongoing technological advancement.
Intended Use
The system is intended for use in photocoagulation and treatment of ocular pathology in the posterior and anterior segments of the eye, as well as for capturing, displaying, storing, and manipulating images of the eye created based on different imaging modalities.
Indications for Use (CE)
Posterior segment:
- Macular edema
- Proliferative and non-proliferative diabetic retinopathy
- Choroidal neovascularization
- Age-related macular degeneration
- Central and branch retinal vein occlusion
- Lattice degeneration, retinal tears and detachments
Anterior segment:
- Open angle glaucoma
- Closed angle glaucoma
Indications for use (FDA)
The system is indicated for use for:
In retinal photocoagulation for the treatment of clinically significant diabetic macular edema (focal or grid laser), proliferative diabetic retinopathy (panretinal photocoagulation), sub-retinal (chorodial) 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 segments of the eye.
In laser trabeculoplasty for primary open angle glaucoma, as well as iridotomy and iridoplasty for closed angle glaucoma.
"Off-label" use
Any other indications not listed herein are considered „off-label“ and the use of Navilas in these indication is upon operators responsibility and liability.
Links
This website contains links to other websites that are not controlled or operated by OD-OS. These links are for your convenience only and shall not constitute any kind of liability of OD-OS whatsoever.
Exclusion of Liability
The information on this website is provided by OD-OS 'as is' and without warranties of any kind, whether expressed, implied, or statutory. It is subject to change without notice. The use of this website is at your own risk, and OD-OS disclaims any liability whatsoever resulting from the use of this website, including but not limited to business interruption or software defects.
Trademarks
Trademarks of OD-OS are indicated by ™ or ®; ™ indicates a pending trademark registration in Europe and/or the US, ® indicates a trademark registration in Europe and/or the US. No licenses or other rights of any kind to any kind of intellectual property are granted by the publication of this website.
Forward-looking statements
This website contains forward-looking statements based on beliefs, view, and/or estimations of OD-OS management at the time such statement is made. Such forward-looking statements are subject to risks and uncertainties. OD-OS disclaims any intention or obligation to correct or update such forward-looking statements.
Changes and Amendments
OD-OS retains the right to change or amend the information on this website without notice in order to further its benefit for the users of our website.