FDA.reportPublic FDA data

Navilas® Laser System 577s

Primary DI
04260284390013
Brand
Navilas® Laser System 577s
Company
OD-OS GmbH
Model
Navilas® Laser System 577s
Catalog number
156000
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.
Published
2023-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HKICamera, Ophthalmic, Ac-Powered
NFFDevice, Storage, Images, Ophthalmic
NFGDevice, Communications, Images, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
NFFDevice, Storage, Images, OphthalmicRadiology1
NFGDevice, Communications, Images, OphthalmicRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162191000NAVILAS Laser SystemOd-Os GmbH2016-11-22GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260284390013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260284390013042602843900134260284390013

GMDN Terms#

Term, Definition table
TermDefinition
Fundus-imaging ophthalmic diode laser systemA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1200 millibar
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius28 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1200 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49332831282100service@od-os.com

Regulatory Flags#

DUNS number
312726983
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260284390082Navilas® Laser System 577slNavilas® Laser System 577sl1566912026-03-01

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