Fully Assisted Refraction System

Basic Information

• Brand Name: Fully Assisted Refraction System
• Primary DI: 04987669203552
• Version / Model: FARS
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-27
• Public Version: 1
• Public Version Date: 2026-04-06
• Public Version Status: New
• Public Device Record Key: 72ea3e27-3b8b-4fb6-b910-0e2d6efc7517

Device Description

In the conventional refraction, the patient answers the operator’s questions. According to their answers, the operator performs subjective refraction such as refining refractive errors (sphere, cylinder, prism, and such) and proceeding to the next test. In this system, the patient responds to refraction questions by themselves using the Joystick Controller in response to the voice guide from the computer. The system application enables subjective refraction according to patient operation to determine the full correction.

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: 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
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	04987669203552	GS1

Customer Contacts

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