Identity
- Trade Name
- VX120+ EUDAMEDVISIONIX FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- VX120+ EUDAMEDThe VX120+ is a multi-function diagnostic device combining 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 cornea. Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height FDA UDI
- Model / Reference
- VX120+ EUDAMEDFDA UDI
- Description
- The VX120+ is a multi-function diagnostic device combining 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 cornea. Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000046 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000046LL EUDAMED
- Direct Marketing DI
- 03664188000046 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 71566616-fb86-4963-87f7-ba24484c9f64 33 fields · synced Jul 11, 2026
- EUDAMED 8bab7f06-96c5-45cc-9084-6320992ea5e4 61 fields · synced Jul 11, 2026