FDA.reportPublic FDA data

TERA Dry Eye Imager

Primary DI
08034028770609
Brand
TERA Dry Eye Imager
Company
VISIA IMAGING SRL
Model
TERA Dry Eye Imager
Catalog number
42-0002941US
Published
2025-08-06
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
MMQTopographer, Corneal, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMQTopographer, Corneal, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034028770609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034028770609080340287706098034028770609

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography systemAn assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.

Sterilization Methods#

Method table
Method

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
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
08034028770401TOPCONSOLOS42-00014172022-09-15
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
08800019600992Auto Ref-Topographer HRKT-1Huvitz Co., Ltd.MMQ2026-01-30
06973211071623Corneal TopographerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDMMQ2025-08-18
06973211071630Corneal TopographerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDMMQ2025-08-18
06972039971054MOPTIMShenzhen CERTAINN Technology Co., Ltd.MMQ2025-08-15
09349221000132Medmont Meridia Advanced Topographer VantageMEDMONT INTERNATIONAL PTY LTDMMQ2025-07-03
08800019600770Corneal Topographer HTG-1Huvitz Co., Ltd.MMQ2023-06-12
03662824001846TearCheck TE-SWINMMQ2023-03-06
03662824003048TearCheck TE-SWINMMQ2023-03-06
06945087500002MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.MMQ2022-11-02
09349221000101Medmont Meridia Advanced Topographer ProfessionalMEDMONT INTERNATIONAL PTY LTDMMQ2022-09-14
09349221000118Medmont Meridia Advanced Topographer ClassicMEDMONT INTERNATIONAL PTY LTDMMQ2022-09-14
04582273603714Topographic Modeling SystemTOMEY CORPORATION.MMQ2022-04-01
08719326059600CASSINICassini Technologies B.V.MMQ2021-03-03
04582273612099TOPOGRAPHIC MODELING SYSTEMTOMEY CORPORATION.MMQ2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTOMEY CORPORATION.MMQ2020-10-30
06945087505175MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.MMQ2020-03-12
04049584000477Keratograph 5MOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMMQ2016-09-01