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Visionix

FDA UDI

Class II (US FDA UDI)

by Luneau Technology Operations

Identity

Trade Name
VISIONIX FDA UDI
Generic Name
Automated ophthalmic refractometer FDA UDI
Device Name
The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination. 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 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
VX130+ FDA UDI
Description
The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination. 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 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
03664188000039 FDA UDI
FDA Product Code
HKX FDA UDI
HKO FDA UDI
MXK FDA UDI
GMDN Term
Automated ophthalmic refractometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1930 FDA UDI
886.1760 FDA UDI
886.1850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Automated ophthalmic refractometerOphthalmic tonometer, battery-operatedOptical pachymeter

Visionix by Luneau Technology Operations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical pachymeter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luneau Technology Operations

Sources (1)

  • FDA UDI ebcf8da6-c223-4c98-992a-1047b12299f5 33 fields · synced Jun 1, 2026