FDA.reportPublic FDA data

Pentacam Cornea OCT

Primary DI
04049584034953
Brand
Pentacam Cornea OCT
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
10019001
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MXKDevice, Analysis, Anterior Segment
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXKDevice, Analysis, Anterior SegmentOphthalmic2
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251848000Pentacam® Cornea OCTOculus Optikgeräte GmbH2026-03-13MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584034953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584034953040495840349534049584034953

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.

Regulatory Flags#

DUNS number
317138956
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04049584034212GONIO ready® CL10012719100127202025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
08034028770517ESSILORVISIA IMAGING SRLMXK2024-11-04
04059237000723SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
00857691006039ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2024-05-02
04059237000938ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04059237000945ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
08034028770487MYAHVISIA IMAGING SRLMXK2023-10-12
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000730HRT3Heidelberg Engineering GmbHMXK2023-03-03
04059237000884SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
08034028770463MYOPIA EXPERT 700VISIA IMAGING SRLMXK2022-06-22
08034028770456MYAHVISIA IMAGING SRLMXK2022-06-14