FDA UDI
In Commercial Distribution
🇺🇸 United States
OTUS® Fixation, Vision Training, Binocular
DI: 08809765430006
·
Model: LRS2-400FB1-M0
·
EDENLUX Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OTUS® Fixation, Vision Training, Binocular
- Primary DI
- 08809765430006
- Version / Model
- LRS2-400FB1-M0
- Company Name
- EDENLUX Corp.
- Labeler DUNS
- 696950408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-07
- Public Version
- 1
- Public Version Date
- 2025-07-15
- Public Version Status
- New
- Public Device Record Key
- 96ea5c65-aa4d-463b-9580-bc85245a7613
Device Description
Vision Training Device, Battery-powered
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NXR | Fixation, Vision Training, Binocular | Ophthalmic | 886.1290 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35656 | Vision training device, battery-powered | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809765430006 | GS1 |