RODENSTOCK

Basic Information

• Brand Name: RODENSTOCK
• Primary DI: 03664188000930
• Version / Model: DNEye Scanner 2+
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Labeler DUNS: 260432380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 4
• Public Version Date: 2025-01-15
• Public Version Status: Update
• Public Device Record Key: a4817618-65df-49c7-a090-dff30959029c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKX	Tonometer, Ac-Powered	Ophthalmic	886.1930	2
MXK	Device, Analysis, Anterior Segment	Ophthalmic	886.1850	2
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	No	Active
65176	Multiple ocular dimension meter	An electrically-powered, ophthalmic device intended to measure multiple dimensional parameters of the eye (e.g., refractive error, corneal anterior surface curvature/thickness, distance between pupils) during an ophthalmic examination, typically to determine a patient's prescription for glasses or evaluate the need for surgery; it not dedicated to measurement of a single dimensional parameter (i.e., it is not a refractometry-, keratometry-, pachymetry-, pupillometry-, or topography-only device). It may be a hand-held or tabletop device, and may be designed for connection to an off-the-shelf computer for device control and/or results analysis/display.	No	Active
67414	Ophthalmic tonometer, professional	An ophthalmic, electrically-powered device intended to be used by a healthcare professional to measure intraocular pressure (IOP) by exerting an external force against the eye, which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation), typically for the diagnosis of glaucoma. It may have a light contact with the eye, have a bench-top or hand-held design, and use various techniques (e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03664188000930	GS1