Navilas® Laser System 577sl

Basic Information

• Brand Name: Navilas® Laser System 577sl
• Primary DI: 04260284390082
• Version / Model: Navilas® Laser System 577sl
• Catalog Number: 156691
• Company Name: OD-OS GmbH
• Labeler DUNS: 312726983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-01
• Public Version: 2
• Public Version Date: 2026-04-24
• Public Version Status: Update
• Public Device Record Key: 09c83602-965c-4396-8ea0-51e71d5a6e86

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61610	Fundus-imaging ophthalmic diode laser system	A mains electricity (AC-powered) device assembly with an integrated fundus camera and a high-power (>5mW) optically-pumped semiconductor laser (OPSL) intended for: 1) ocular laser treatment procedures, including coagulation of abnormal retinal vasculature; and 2) capturing real-time digital images of the anterior/posterior eye segments created using colour, fluorescein angiography and infrared imaging, for diagnosis/treatment planning. The laser utilizes a diode pumping laser to excite a semiconductor chip (active medium) to emit a laser beam which is doubled in frequency (e.g., to 532nm, 577nm). It may include treatment planning software; it does not include femtosecond pulsing technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260284390082	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1200 millibar
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 28 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1200 millibar
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 60 Degrees Celsius