Navilas® Laser System 577s

Basic Information

• Brand Name: Navilas® Laser System 577s
• Primary DI: 04260284390013
• Version / Model: Navilas® Laser System 577s
• Catalog Number: 156000
• Company Name: OD-OS GmbH
• Labeler DUNS: 312726983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: fcfbe706-3c70-4e6a-8cb7-62b948ed8f4b

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2
NFF	Device, Storage, Images, Ophthalmic	Radiology	892.2010	1
NFG	Device, Communications, Images, Ophthalmic	Radiology	892.2020	1

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	04260284390013	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162191	000

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