RODENSTOCK

GUDID 03664188000923

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

LUNEAU TECHNOLOGY OPERATIONS

Automated ophthalmic refractometer
Primary Device ID03664188000923
NIH Device Record Keyea738487-6044-4ab6-9ba9-f7a289de85d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRODENSTOCK
Version Model NumberDNEye Scanner 2
Company DUNS260432380
Company NameLUNEAU TECHNOLOGY OPERATIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103664188000923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKXTonometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [RODENSTOCK]

03664188000930DNEye Scanner 2+
03664188000923The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combine

Trademark Results [RODENSTOCK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RODENSTOCK
RODENSTOCK
72184774 0771867 Live/Registered
Rodenstock; Rudolph
1963-12-30

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