FDA.reportPublic FDA data

Keratograph 5M

Primary DI
04049584000477
Brand
Keratograph 5M
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
7700
Device description
The OCULUS Keratograph 5M combines the keratometric measuring processwith topographic mapping.Measurement of the corneal surface is done by means of a Placido ringsystem that is reflected off the cornea. These data are analyzed by thecomputer.
Published
2016-09-01
Public version status
Update
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
04049584000477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584000477040495840004774049584000477

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth400Millimeter
Height512Millimeter
Weight6.1Kilogram
Width275Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 Percent (%) Relative Humidity106 Percent (%) Relative Humidity
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

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
08034028770609TERA Dry Eye ImagerVISIA IMAGING SRLMMQ2025-08-06
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