ILLUMINIX

Basic Information

• Brand Name: ILLUMINIX
• Primary DI: 00860010833278
• Version / Model: ESSENCE
• Company Name: Illuminix Industries LLC
• Labeler DUNS: 114867460
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-23
• Public Version: 1
• Public Version Date: 2024-01-31
• Public Version Status: New
• Public Device Record Key: 2e6d44b9-e948-46b7-b85e-b88f656e5c5f

Device Description

Refractor instrument for trial lenses for subjective eye refraction examiation

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	886.1770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66910	Phoropter, electric	An electrically-powered ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as an automated or digital refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist changes the lenses and other settings via an electrical control unit, while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010833278	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]