FDA.reportPublic FDA data

COMPUTERIZED LENSMETER CL-300

Primary DI
04562123288384
Brand
COMPUTERIZED LENSMETER CL-300
Company
TOPCON CORPORATION
Model
CL-300
Published
2023-12-19
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
HLMInstrument, Measuring, Lens, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLMInstrument, Measuring, Lens, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562123288384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562123288384045621232883844562123288384

GMDN Terms#

Term, Definition table
TermDefinition
Automated lensmeterA mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results.

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
04560126268549COMPU 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04540008320138RexxamREXXAM CO., LTD.HLM2026-04-20
04540008320145RexxamREXXAM CO., LTD.HLM2026-04-20
04540008320152RexxamREXXAM CO., LTD.HLM2026-04-20
04987669204924AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
04987669204979AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
04987669205020AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
00860014277535S4Optik AL 2000 Digital LensmeterLombart Brothers, Inc.HLM2025-10-18
03664188000602VISIONIXLUNEAU TECHNOLOGY OPERATIONSHLM2025-09-05
00812559012270LensChekPlusREICHERT, INC.HLM2025-08-12
00812559012287LensChekProREICHERT, INC.HLM2025-08-12
08034028770524TOPCONVISIA IMAGING SRLHLM2025-02-20
06971922131292YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2024-08-08
04562123288391COMPUTERIZED LENSMETER CL-300TOPCON CORPORATIONHLM2023-12-19
03615020000038ALM500ESSILOR INTERNATIONALHLM2023-10-03
03615020000120ALM700ESSILOR INTERNATIONALHLM2023-10-03
03615020000236ALM800ESSILOR INTERNATIONALHLM2023-10-03
07290018993804MyRx LensScaner 6 OVER 6 VISION LTDHLM2023-08-30
72900189938040MyRx LensScaner 6 OVER 6 VISION LTDHLM2023-08-30
03664188000329VisionixLUNEAU TECHNOLOGY OPERATIONSHLM2023-06-08
03664188000541VisionixLUNEAU TECHNOLOGY OPERATIONSHLM2023-06-08
08800074500244Auto LensmeterVIEW-M TECHNOLOGY CO., LTD.HLM2023-01-10
08800074500251Auto LensmeterVIEW-M TECHNOLOGY CO., LTD.HLM2023-01-10
05070000542829AtlasEyoto, Inc.HLM2022-11-17
05070000542836AtlasEyoto, Inc.HLM2022-11-17
08034028770401TOPCONVISIA IMAGING SRLHLM2022-09-15
04562123280531PRISM COMPENSATOR for LENSMETER LM-8TOPCON CORPORATIONHLM2022-08-31
06971922131070YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21
06971922131674YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21
06971922131728YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21
06971922131926YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21