FDA.reportPublic FDA data

ENVISU C2300 VHR 100V

Primary DI
00857691006367
Brand
ENVISU C2300 VHR 100V
Company
BIOPTIGEN, INC.
Model
90-C2300-V1-100
Published
2020-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBOTomography, optical coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBOTomography, Optical CoherenceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857691006367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857691006367008576910063678576910063670857691006367

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spectral-domain optical coherence tomography systemA mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Contacts#

Phone, Email table
PhoneEmail
+1(984)7105152Iris.Pohl@leica-microsystems.com

Regulatory Flags#

DUNS number
361420040
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857691006343ENFOCUS 4400 VHR 100V90-C4450-H2-1002020-06-01
00857691006022ENVISU C2300 VHR 120V90-C2300-V1-1202016-09-16
00857691006053ENVISU C2300 VHR 220V90-C2300-V1-2202016-09-16
00857691006107ENFOCUS 4400 HR 120V90-C4450-H2-1202016-09-16
00857691006114ENFOCUS 4400 HR 220V90-C4450-H2-2202016-09-16
00857691006039ENFOCUS 2300 INTEGRATED OCT900C23550V52024-05-02
00857691006336ENFOCUS 2300 VHR 100V90-C2350-V2-1002020-06-01
00857691006084ENFOCUS 2300 VHR 120V90-C2350-V2-1202016-09-16
00857691006091ENFOCUS 2300 VHR 220V90-C2350-V2-2202016-09-16
00857691006374ENFOCUS 2300 INTEGRATED OCT90-C2350-V42020-11-19

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
00857691006336ENFOCUS 2300 VHR 100VBIOPTIGEN, INC.OBO2020-06-01