FDA.reportPublic FDA data

ILLUMINIX

Primary DI
00860010833292
Brand
ILLUMINIX
Company
Illuminix Industries LLC
Model
EagleSight RefraScan
Device description
Auto Refractor and Keratometer
Published
2024-01-23
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
HKORefractometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010833292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010833292008600108332928600108332920860010833292

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 290 5140info@illuminixeye.com

Regulatory Flags#

DUNS number
114867460
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010833209ILLUMINIXCLARICON2024-01-23
00860010833216ILLUMINIXORBIT COMFORT2024-01-23
00860010833223ILLUMINIXORBIT2024-01-23
00860010833247ILLUMINIXCLARICON MAX2024-01-23
00860010833261ILLUMINIXCLARCION MAX Z2024-01-23
00860010833278ILLUMINIXESSENCE2024-01-23
00860010833285ILLUMINIXSMART CHART2024-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972039971092MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKO2026-06-03
06971922136334YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2026-04-25
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310603RexxamREXXAM CO., LTD.HKO2025-10-17
06973211071869Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
06973211071876Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
00812559012249OptochekPlusREICHERT, INC.HKO2025-08-12
04571130283381AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PATOPCON CORPORATIONHKO2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKO2025-05-01
04571130283367AUTO KERATO-REFRACTOMETER KR-800ATOPCON CORPORATIONHKO2025-04-15
B43050085500GoCheck KidsGobiquity, Inc.HKO2025-03-20
03664188000169VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02