Luxvision

Basic Information

• Brand Name: Luxvision
• Primary DI: 00851158007720
• Version / Model: RU-1000
• Company Name: U.S. OPHTHALMIC, L.L.C.
• Labeler DUNS: 166760392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-14
• Public Version: 1
• Public Version Date: 2021-10-22
• Public Version Status: New
• Public Device Record Key: cffcd012-5879-491d-bbcc-fa760c240295

Device Description

Ophthalmic Refraction unit RU-1000

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	886.1140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62613	Ophthalmic examination station	A mains electricity (AC-powered) device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician. It consists of a chair to position the patient in a seated or reclined posture for easy access and comfort, a stand designed as a column or post used to provide support and position control for devices commonly used during an ophthalmic examination, and a table designed as a work surface to support ophthalmic instruments. It has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient to facilitate examination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851158007720	GS1