Identity
- Trade Name
- VX130 EUDAMEDVISIONIX FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- VX130 EUDAMEDThe VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer 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 central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris FDA UDI
- Model / Reference
- VX130 EUDAMEDFDA UDI
- Description
- The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer 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 central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000909 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000909MT EUDAMED
- Direct Marketing DI
- 03664188000909 EUDAMED
- FDA Product Code
- HKX FDA UDIHKO FDA UDIMXK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI886.1760 FDA UDI886.1850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Automated ophthalmic refractometerOphthalmic tonometer, battery-operatedOptical pachymeter
Visionix by Luneau Technology Operations — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Optical pachymeter.
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI a06715ef-136a-41eb-9b3b-30a2d01b7a69 33 fields · synced Jul 30, 2026
- EUDAMED 34722847-7d76-4857-9ebb-f5f7ce3183c1 61 fields · synced Jul 30, 2026