| Primary Device ID | 04260284390082 |
| NIH Device Record Key | 09c83602-965c-4396-8ea0-51e71d5a6e86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navilas® Laser System 577sl |
| Version Model Number | Navilas® Laser System 577sl |
| Catalog Number | 156691 |
| Company DUNS | 312726983 |
| Company Name | OD-OS GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com | |
| Phone | +49332831282100 |
| service@od-os.com |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 26 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1200 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260284390082 [Primary] |
| HQF | Laser, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-09 |
| Device Publish Date | 2026-03-01 |
| 04260284390082 - Navilas® Laser System 577sl | 2026-03-09The Navilas® Laser System 577sl is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System 577sl 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. |
| 04260284390082 - Navilas® Laser System 577sl | 2026-03-09 The Navilas® Laser System 577sl is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System |
| 04260284390013 - Navilas® Laser System 577s | 2023-11-29 The Navilas® Laser System 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NAVILAS 79065078 3667055 Live/Registered |
OD-OS GmbH 2008-12-03 |