FDA.reportPublic FDA data

YEASN

Primary DI
06971922136334
Brand
YEASN
Company
Chongqing Yeasn Science & Technology Co.,Ltd.
Model
YPC-100K
Device description
The eye refractometer measures the objective refractive errors (including spherical, cylindrical refractive errors, cylinder axis) and corneal curvature radius of the patient’s eye (including corneal refractive power, principle meridian directions, and corneal cylindrical power).
Published
2026-04-25
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
06971922136334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971922136334069719221363346971922136334

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.

Regulatory Flags#

DUNS number
547954649
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971922132299YEASNYPA-2100S2026-05-01
06971922133319YEASNYPB-2100P2026-05-01
06971922132770YEASNSLY-1002025-04-08
06971922132558YEASNMPH150MPH1502024-11-30
06971922132787YEASNMPH150MPH150BN2024-11-30
06971922132794YEASNMPH150MPH150BP2024-11-30
06971922136037YEASNYPC-1002024-08-21
06971922131070YEASNCCQ-800CCQ8/102022-04-21
06971922132725YEASNSLY-100SLY1/392022-04-21
06971922133029YEASNYPB-2100YPB21/12022-04-21
06971922131377YEASNCCQ1100CCQ11/22022-03-05
06971922132046Digital RefractorYPA-2100YPA21/32021-11-29
06971922130097FocimeterCCQ-4002021-03-03
06971922130103FocimeterCCQ-5002021-03-03
06971922130110Auto FocimeterCCQ-11002021-03-03
06971922130042Auto FocimeterCCQ-8002020-10-22
06971922130066LCD Visual ChartYPB-21002020-10-22
06971922130073Digital RefractorYPA-21002020-10-22
06971922130080PupilometerHX-4002020-10-22
06971922131001VISION TESTERSLY-1002020-10-20

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Primary DI, Brand, Company table
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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
B43071000020GoCheck MultiScreenerGobiquity, Inc.HKO2024-09-23