Navilas® Laser System 577s 156000

GUDID 04260284390013

The Navilas® Laser System 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System 577s 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.

OD-OS GmbH

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• Primary Device ID: 04260284390013
• NIH Device Record Key: fcfbe706-3c70-4e6a-8cb7-62b948ed8f4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navilas® Laser System 577s
• Version Model Number: Navilas® Laser System 577s
• Catalog Number: 156000
• 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

Customer Support Contacts

• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com
• Phone: +49332831282100
• Email: service@od-os.com

Operating and Storage Conditions

• 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 15 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 Identifiers

Device Issuing Agency	Device ID
GS1	04260284390013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162191

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-29
• Device Publish Date: 2023-11-21