OTUS® Fixation, Vision Training, Binocular

Primary DI
08809765430006
Brand
OTUS® Fixation, Vision Training, Binocular
Company
EDENLUX Corp.
Model
LRS2-400FB1-M0
Device description
Vision Training Device, Battery-powered
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NXRFixation, Vision Training, Binocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXRFixation, Vision Training, BinocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809765430006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809765430006088097654300068809765430006

GMDN Terms#

Term, Definition table
TermDefinition
Vision training device, battery-poweredA battery-powered device with a series of individual flashing light sources [typically consisting of a light-emitting diode (LED)] to treat poor accommodative and vergence facility, convergence insufficiency, and large accommodative lag in non-presbyopic subjects. It is designed as a long metal or plastic bar upon which the lights are mounted at intervals and the patient, placed in front it, tracks the movement of the flashing lights as they rapidly change positon. Some types use alternating red and blue lights making use of the phenomenon of chromatic aberration to gently rock accommodation and convergence of the lens. It is suitable for home-use but may be used in an optometrist's office.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696950408
Device count
1
DM exempt
true
Premarket exempt
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B091151330Brock StringGulden Ophthalmics Inc.NXR2023-07-05
00860010599716NeuroEyeCoachNovavision, Inc.NXR2023-07-03
00850029104650FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2023-02-05
00850029104414FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29
08500291040492FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29