FDA.reportPublic FDA data

Corneal Topographer HTG-1

Primary DI
08800019600770
Brand
Corneal Topographer HTG-1
Company
Huvitz Co., Ltd.
Model
HTG-1
Catalog number
HTG-1
Device description
Corneal Topographer HTG-1
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

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
08800019600770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600770088000196007708800019600770

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

Contacts#

Phone, Email table
PhoneEmail
+82314289100svc@huvitz.com

Regulatory Flags#

DUNS number
688154202
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
08800019600121Imaging System HIS-5000UHIS-5000UHIS-5000U2019-05-10
08800019600954Vision ScreenerHVS-12026-02-13
08800019600992Auto Ref-Topographer HRKT-1HRKT-12026-01-30
08800019601074Visual Acuity Chart System HDC-100HDC-1002025-11-19
08800019601005LilivisLS-100-TIP-3R2025-09-08
08800019600794Huvitz Integrated Image Server HIIS-1HIIS-12025-08-14
08800019600961OCTiX IntraOral ScannerLSO-100Y4XXCL-24-000012024-11-26
00880019600961Lilivis SCAN OPTOMOLSO-100Y4XXCL-24-000012024-11-26
08800019600978Instrument Table CIT-4100CIT-41002024-06-24
08800019600985Instrument Table CIT-4200CIT-42002024-06-24
08800019600893Lilivis Scan LS-100LS-100LS-1002024-05-27
08800019600909Lilivis CAD L-CADL-CADLS-1002024-05-27
08800019600411Applanation Tonometer HT-5000HT-5000HT-50002023-06-12
08800019600787Optical Biometer HBM-1HBM-12023-10-18
08800019600916Digital Refractor HDR-7100PHDR-7100P2023-08-24
08800019600923Auto Ref/Keratometer HRK-8100AHRK-8100A2023-08-24
08800019600435Non-contact Tonometer HNT-1PHNT-1PHNT-1P2023-06-12
08800019600503Ref-Keratometer ERK-9100ERK-9100ERK-91002023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHTR-1AHTR-1A2023-06-12
08800019600732Digital Chart HDC-9100NHDC-9100NHDC-9100N2023-06-12

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
08034028770609TERA Dry Eye ImagerVISIA IMAGING SRLMMQ2025-08-06
09349221000132Medmont Meridia Advanced Topographer VantageMEDMONT INTERNATIONAL PTY LTDMMQ2025-07-03
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