FDA.reportPublic FDA data

COMPU VISION CV-5000

Primary DI
04560126268549
Brand
COMPU VISION CV-5000
Company
TOPCON CORPORATION
Model
CV-5000
Published
2025-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04560126268549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560126268549045601262685494560126268549

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
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
04562123288315SPECULAR MICROSCOPE SP-1PSP-1P2016-09-19
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000MC-5S2025-12-09
04560126269188AUTO KERATO-REFRACTOMETER KR-1KR-12025-11-21
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATRK-32025-11-17
04560126269140AUTO KERATO-REFRACTOMETER KR-800KR-8002025-10-31
04560126269164AUTO REFRACTOMETER RM-800RM-8002025-10-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)3D OCT-12025-09-11
04571130283381AUTO KERATO-REFRACTOMETER KR-1KR-12025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PAKR-800PA2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosSNi-12025-05-01
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000SNi-12025-02-27
04571130283367AUTO KERATO-REFRACTOMETER KR-800AKR-800A2025-04-15
04562123288179COMPUTERIZED TONOMETER CT-80CT-802016-09-19
04560126268532COMPU VISION CV-5000CV-50002025-02-27
045601262685701DIAL CONTROLLER KB-50SKB-50S2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04571130282773REFRACTION SYSTEM ChronosChronos2024-08-01
04571130283350AUTO KERATO-REFRACTOMETER KR-800KR-8002024-05-09
04571130283374AUTO REFRACTOMETER RM-800RM-8002024-05-09

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
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
06971922132558YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2024-11-30