FDA UDI
In Commercial Distribution
🇺🇸 United States
Visionix
DI: 03664188000060
·
Model: VX110
·
LUNEAU TECHNOLOGY OPERATIONS
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Visionix
- Primary DI
- 03664188000060
- Version / Model
- VX110
- Company Name
- LUNEAU TECHNOLOGY OPERATIONS
- Labeler DUNS
- 260432380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 14180ca2-32a6-45fc-ac32-7ab3fa7a50ff
Device Description
The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| HKO | Refractometer, Ophthalmic | Ophthalmic | 886.1760 | 1 |
| MXK | Device, Analysis, Anterior Segment | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36386 | Automated ophthalmic refractometer | An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision. | No | Active |
| 13236 | Pupillometer, electrically-powered | An electrically-powered ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. The patient will, e.g., view into this device and the operator will see the pupil and its shape. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03664188000060 | GS1 |