Fully Assisted Refraction System

Primary DI
04987669203552
Brand
Fully Assisted Refraction System
Company
NIDEK CO.,LTD.
Model
FARS
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.
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKNRefractor, Manual, Non-Powered, Including Phoropter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKNRefractor, Manual, Non-Powered, Including PhoropterOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669203552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669203552049876692035524987669203552

GMDN Terms#

Term, Definition table
TermDefinition
Phoropter, electricAn 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.

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31

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Primary DI, Brand, Company table
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00628308210480LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210497S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210503LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210510S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210527LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00860014277542S4 OptikLombart Brothers, Inc.HKN2025-10-18
04540008310429RexxamREXXAM CO., LTD.HKN2025-10-17
00812559010238Ultramatic RX Master PhoropterREICHERT, INC.HKN2025-08-12
00812559010269Ultramatic RX Master PhoropterREICHERT, INC.HKN2025-08-12
00812559010290Illuminated PhoropterREICHERT, INC.HKN2025-08-12
00812559010320Illuminated PhoropterREICHERT, INC.HKN2025-08-12
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00812559012263SightChek Digital PhoropterREICHERT, INC.HKN2025-08-12
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04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)TOPCON CORPORATIONHKN2025-02-27
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