FDA.reportPublic FDA data

Digital Refractor

Primary DI
06971922130073
Brand
Digital Refractor
Company
Chongqing Yeasn Science & Technology Co.,Ltd.
Model
YPA-2100
Device description
To check the refractive state of human eye.
Published
2020-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06971922130073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971922130073069719221300736971922130073

GMDN Terms#

Term, Definition table
TermDefinition
PhoropterA mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient's prescription for glasses. It consists of two large, disk-like housings, joined together, that each contain a built-in paternoster works consisting of a large number of different lenses of differing strengths used to measure the refraction of the eye; it is a mechanized set of trial lenses. It is placed in front of the patient's eyes and viewing through the phoropter the patient is asked to read a Snellen eye chart placed at a preset distance. The optometrist changes the lenses and other settings, while asking the patient for subjective feedback on which settings give best vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547954649
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971922132299YEASNYPA-2100S2026-05-01
06971922133319YEASNYPB-2100P2026-05-01
06971922136334YEASNYPC-100K2026-04-25
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
06971922130080PupilometerHX-4002020-10-22
06971922131001VISION TESTERSLY-1002020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922132299YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2026-05-01
00628308210473S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
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
04987669203552Fully Assisted Refraction SystemNIDEK CO.,LTD.HKN2026-03-27
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
00812559011716Phoropter VRxREICHERT, INC.HKN2025-08-12
00812559011730Phoropter VRxREICHERT, INC.HKN2025-08-12
00812559012263SightChek Digital PhoropterREICHERT, INC.HKN2025-08-12
00860014277504Advancing EyecareLombart Brothers, Inc.HKN2025-07-21
06972039971016MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-23
06972039971023MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-23
06972039971214MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKN2025-06-19
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosTOPCON CORPORATIONHKN2025-05-01
06971922132770YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2025-04-08
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
04560126268532COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
04560126268549COMPU VISION CV-5000TOPCON CORPORATIONHKN2025-02-27
045601262685701DIAL CONTROLLER KB-50STOPCON CORPORATIONHKN2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)TOPCON CORPORATIONHKN2025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)TOPCON CORPORATIONHKN2025-02-27
03664188000077VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKN2025-01-02