Navilas® Laser System 577sl 156691

GUDID 04260284390082

The 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.

OD-OS GmbH

Fundus-imaging ophthalmic diode laser system
Primary Device ID04260284390082
NIH Device Record Key09c83602-965c-4396-8ea0-51e71d5a6e86
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavilas® Laser System 577sl
Version Model NumberNavilas® Laser System 577sl
Catalog Number156691
Company DUNS312726983
Company NameOD-OS GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com
Phone+49332831282100
Emailservice@od-os.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 26 Degrees Celsius and 28 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1200 millibar
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260284390082 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-09
Device Publish Date2026-03-01

Devices Manufactured by OD-OS GmbH

04260284390082 - Navilas® Laser System 577sl2026-03-09The 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 577sl2026-03-09 The Navilas® Laser System 577sl is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System
04260284390013 - Navilas® Laser System 577s2023-11-29 The Navilas® Laser System 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System

Trademark Results [Navilas]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NAVILAS
NAVILAS
79065078 3667055 Live/Registered
OD-OS GmbH
2008-12-03

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