Rodenstock

FDA UDI

Class II (US FDA UDI)

by Luneau Technology Operations

Identity

Trade Name: RODENSTOCK 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 FDA UDI
Model / Reference: DNEye Scanner 2 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 03664188000923 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Automated ophthalmic refractometer Ophthalmic tonometer, battery-operated

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Luneau Technology Operations

Sources (1)

FDA UDI ea738487-6044-4ab6-9ba9-f7a289de85d6 33 fields · synced Jun 8, 2026