FDA.reportPublic FDA data

PLEX Elite

Primary DI
04057748087110
Brand
PLEX Elite
Company
Carl Zeiss Meditec, Inc.
Model
9000
Device description
The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographicand biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging ofposterior ocular structures.
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161194000PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.2016-10-26OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057748087110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057748087110040577480871104057748087110

GMDN Terms#

Term, Definition table
TermDefinition
Retinal optical coherence tomography systemAn assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362747011
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057748087141CIRRUS HD-OCT 60002019-11-01
04057748087080CIRRUS HD-OCT50002016-04-15
04057748087097CIRRUS HD-OCT5002016-08-25
04057748087127CIRRUS HD-OCTCIRRUS Review Software2017-04-14
04057748096044CLARUS7002019-07-01
04057748085284Humphrey Field Analyzer 3 (HFA3) HFA3 Review Software2019-03-22
04057748096037CLARUS5002017-09-25
04057748096051CLARUSCLARUS Review Software 2017-09-25
04057748081118ATLAS Corneal Topography System90002018-06-13
04057748085215Humphrey FDT7102018-06-13
04057748085239Humphrey Matrix 8002018-06-13
04057748085246Humphrey Field Analyzer 3 (HFA3)8302017-01-11
04057748085253Humphrey Field Analyzer 3 (HFA3)8402017-01-11
04057748085260Humphrey Field Analyzer 3 (HFA3)8502017-01-11
04057748085277Humphrey Field Analyzer (HFA3)8602017-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
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
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000884SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
04059237000754ANTERIONHeidelberg Engineering GmbHOBO2022-02-14
04059237000815SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHOBO2022-02-02
045711302829573D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2022-01-28
04059237000617ANTERIONHeidelberg Engineering GmbHOBO2022-01-03
03615020000496ANAEYES OCT for system linkageESSILOR INTERNATIONALOBO2021-02-18
04571130282186ANTERIOR ATTACHMENT HA-2TOPCON CORPORATIONOBO2021-02-03
04571130282193ANTERIOR SEGMENT ATTACHMENT KIT AA-1TOPCON CORPORATIONOBO2021-01-15
00850003069302IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-12-09
00857691006374ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2020-11-19
00858848006766iFusionOPTOVUE, INC.OBO2020-08-24
00850003069241IMAGEnet 6TOPCON HEALTHCARE SOLUTIONS, INC.OBO2020-06-23
00857691006367ENVISU C2300 VHR 100VBIOPTIGEN, INC.OBO2020-06-01