FDA.reportPublic FDA data

TAKAGI

Primary DI
04560323644153
Brand
TAKAGI
Company
TAKAGI SEIKO CO.,LTD.
Model
VIEW TESTER VT-5
Published
2021-12-06
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
04560323644153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560323644153045603236441534560323644153

GMDN Terms#

Term, Definition table
TermDefinition
PhoropterAn ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690907167
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
04560323640940MARCOMARCO ULTRA M2 BI2024-03-14
04560323649165MARCOMARCO DELUXE STAND2023-09-08
04560323640902TAKAGIChart Projector CP-402023-06-09
04560323641114TAKAGISlitlamp Microscope 2ZL2023-06-09
04560323641121TAKAGISlitlamp Microscope 700GL2023-06-09
04560323641176TAKAGISlitlamp Microscope 30GL2023-06-09
04560323641183TAKAGISlitlamp Microscope 4ZL2023-06-09
04560323643804TAKAGIPROJECTION PERIMETER MT 325UD2023-06-09
04560323648564TAKAGIAT-12023-06-09
04560323649158MARCOMARCO BRAVO STAND2023-06-09
04560323641138TAKAGIMobile Slit lamp MS12021-12-06
04560323648427MARCOMARCO ULTRA M52017-04-26
04560323648434MARCOMARCO ULTRA M22017-04-25
04560323648465MARCOMARCO ULTRA M42017-04-25
04560323648472MARCOMARCO ULTRA M32017-04-25
06909071671161MARCOMARCO G4 ULTRA SLITLAMP2016-08-23
06909071671178MARCOMARCO ULTRA2016-07-22
06909071671185MARCOMARCO 5 ULTRA SLITLAMP2016-08-26
06909071671192MARCOMARCO 2B ULTRA SLITLAMP2016-08-26
06909071671215MARCOMARCO G2 ULTRA SLITLAMP2016-08-26

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