FDA.reportPublic FDA data

Tabletop Refraction System

Primary DI
04987669101414
Brand
Tabletop Refraction System
Company
NIDEK CO.,LTD.
Model
TS-310
Device description
The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box.• With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances.• The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.
Published
2017-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKNRefractor, Manual, Non-Powered, Including Phoropter
HOXChart, Visual Acuity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKNRefractor, Manual, Non-Powered, Including PhoropterOphthalmic1
HOXChart, Visual AcuityOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987669101414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987669101414049876691014144987669101414

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training chartAn ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-223-9044info@nidek.com

Regulatory Flags#

DUNS number
690635461
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987669204924AUTO LENSMETERLM-12026-04-20
04987669204979AUTO LENSMETERLM-1P2026-04-20
04987669205020AUTO LENSMETERLM-1PD2026-04-20
04987669101568Scanning Laser OphthalmoscopeMirante2023-06-12
04987669100202GREEN LASER PHOTOCOAGULATOR SYSTEMGYC-10002016-06-24
04987669100226Attachable delivery unit (30SL) 17401-00002017-02-01
04987669100233Attachable delivery unit (SL-1800) 17402-00002017-02-01
04987669100240Attachable delivery unit (SL130) 17404-00002017-02-01
04987669100257Attachable delivery unit (900BQ) 17172-00002017-02-01
04987669100271BIO delivery unit (Keeler) 17120-00002017-02-03
04987669100288BIO delivery unit (Heine OMEGA)17112-00002017-02-03
04987669100295Dual delivery unit17174-00002017-02-03
04987669100301Endophotocoagulation delivery unit17118-00002017-02-03
04987669100318Combination attachable delivery unit (YC-1800) 17148-00002017-02-03
04987669100516OPTICAL COHERENCE TOMOGRAPHYRS-3000 Advance2016-06-24
04987669100998DIGITAL MEDICAL SCOPEDS-10F2016-09-13
04987669101001DIGITAL MEDICAL SCOPEDS-20F2017-01-27
04987669101018DIGITAL MEDICAL SCOPEDS-10A2017-01-27
04987669101025DIGITAL MEDICAL SCOPEDS-10D2017-01-31
04987669101032DIGITAL MEDICAL SCOPEDS-10E2017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971922132299YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2026-05-01
06971922133319YEASNChongqing Yeasn Science & Technology Co.,Ltd.HOX2026-05-01
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
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000TOPCON CORPORATIONHOX2025-12-09
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
00860014277542S4 OptikLombart Brothers, Inc.HKN2025-10-18
04540008310429RexxamREXXAM CO., LTD.HKN2025-10-17
04540008310580RexxamREXXAM CO., LTD.HOX2025-10-17
04540008310610RexxamREXXAM CO., LTD.HOX2025-10-17
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
00812559012003NearBrightREICHERT, INC.HOX2025-08-12
00812559012010NearBrightREICHERT, INC.HOX2025-08-12
00812559012201ClearChart4REICHERT, INC.HOX2025-08-12