FDA.reportPublic FDA data

Norlase LION photocoagulator

Primary DI
05700002165428
Brand
Norlase LION photocoagulator
Company
Norlase ApS
Model
N006-9200
Device description
The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700002165428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700002165428057000021654285700002165428

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular laser ophthalmoscopeA mains electricity (AC-powered), head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305483903
Device count
1
HCT/P
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700002165466Norlase LYNX photocoagulatorN008-92002024-10-30
05700002165442Norlase LEAF photocoagulatorN005-9010-Z2023-12-06
05700002165459Norlase ECHO photocoagulatorN007-9200-Z2023-12-06
05700002165435Norlase ECHO photocoagulatorN007-92002022-11-15
05700002165411Norlase Leaf photocoagulatorN005-9010-032019-10-12

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