FDA.reportPublic FDA data

Visionix

Primary DI
04580606431652
Brand
Visionix
Company
RIGHT MFG. CO., LTD.
Model
Retinomax 5
Catalog number
VSN5100TB
Device description
Tulip Chart SET
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04580606431652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580606431652045806064316524580606431652

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

Regulatory Flags#

DUNS number
713383495
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562230698458RightonRetinomax K+ScreeenRDA1152AA2022-12-09
04562230698502RightonRetinomax K+ScreeenRDA1182AA2022-12-09
04562230698557RightonRetinomax K+ScreeenRDA1172AA2022-12-09
04562230698755RightonRetinomax K+ScreeenRDA1152BA2022-12-09
04562230698809RightonRetinomax K+ScreeenRDA1182BA2022-12-09
04562230698854RightonRetinomax K+ScreeenRDA1172BA2022-12-09
04580606430020RightonRetinomax 5RDA2112AA2022-12-09
04580606430075RightonRetinomax 5RDA2142AA2022-12-09
04580606430129RightonRetinomax 5RDA2132AA2022-12-09
04580606430174RightonRetinomax K-plus5RDA2152AA2022-12-09
04580606430228RightonRetinomax K-plus5RDA2182AA2022-12-09
04580606430273RightonRetinomax K-plus5RDA2172AA2022-12-09
04580606430327RightonRetinomax 5RDA2112BA2022-12-09
04580606430372RightonRetinomax 5RDA2142BA2022-12-09
04580606430426RightonRetinomax 5RDA2132BA2022-12-09
04580606430471RightonRetinomax K-plus5RDA2152BA2022-12-09
04580606430525RightonRetinomax K-plus5RDA2182BA2022-12-09
04580606430570RightonRetinomax K-plus5RDA2172BA2022-12-09
04562230696607RightonSpeedy-K2RDA811AB2022-11-30
04562230698298RightonRetinomax ScreeenRDA1112AA2022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKO2025-01-02