FDA.reportPublic FDA data

TOPCON

Primary DI
08034028770401
Brand
TOPCON
Company
VISIA IMAGING SRL
Model
SOLOS
Catalog number
42-0001417
Device description
instrument intended for use by an optometric/ ophthalmic professional to measure spectacles and single lens properties.
Published
2022-09-15
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
08034028770401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034028770401080340287704018034028770401

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.

Regulatory Flags#

DUNS number
447668039
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034028770609TERA Dry Eye ImagerTERA Dry Eye Imager42-0002941US2025-08-06
08034028770524TOPCONSOLOS LITE42-00027702025-02-20
08034028770562TOPCONCC-100 HW6.03002002025-02-20
08034028770517ESSILORMYOPIA EXPERT 700BMT000042024-11-04
08034028770487MYAHMYAH42-0000983US2023-10-12
08034028770470SeeNASeeNASEENA0061002023-05-26
08034028770319TOPCONCC-1001205033002022-09-15
08034028770326TOPCONCC-100XP1205132002022-09-15
08034028770418TOPCONHENSON 9000HENSON90002022-09-15
08034028770463MYOPIA EXPERT 700MYOPIA EXPERT 700BMT000042022-06-22
08034028770456MYAHMYAH42-0000983US2022-06-14
08034028770364ALADDIN-M12402132020-09-09
08034028770180ALADDIN TMS124040012404002016-09-26
08034028770203ALADDIN HW3.0TEM1240212EXTEM1240212EX2016-11-03
08034028770333ALADDIN HW3.01240212US1240212US2016-12-14

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
04562123288384COMPUTERIZED LENSMETER CL-300TOPCON CORPORATIONHLM2023-12-19
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
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