FDA.reportPublic FDA data

VisionOne

Primary DI
07649990085074
Brand
VisionOne
Company
PeriVision SA
Model
001.001.005
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HPTPerimeter, Automatic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649990085074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649990085074076499900850747649990085074

GMDN Terms#

Term, Definition table
TermDefinition
Perimeter, automaticA mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480583499
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649990085036VisionOneV1.0.02024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2026-01-14
00860011691761Radius InspireRadiusXR, Inc.HPT2025-09-22
G617RVF2001RetinaLogikRetinalogik Inc.HPT2025-03-07
G617RVF1001RetinaLogikRetinalogik Inc.HPT2024-12-02
04582275270075NAKONAN MEDICAL USA, INC.HPT2024-08-02
07649990085036VisionOnePeriVision SAHPT2024-02-28
00860001720433Virtual FieldField Virtual IncHPT2023-11-08
00853569007108PalmScan VF2000Micro Medical Devices, Inc.HPT2023-08-16
00853569007122PalmScan DA2000Micro Medical Devices, Inc.HPT2023-08-16
00860010599709Vision Restoration TherapyNovavision, Inc.HPT2023-07-03
04573277310111imovifaCREWT MEDICAL SYSTEMS, INC.HPT2023-06-16
08800019600824Automated Perimetery HVF-100 Huvitz Co., Ltd.HPT2023-06-12
00860008686015VisuALL VRP ETSOlleyes, Inc.HPT2023-04-26
00860008686022VisuALL VRP SOlleyes, Inc.HPT2023-04-26
00860001720402Virtual FieldVirtual Field, Inc.HPT2023-01-23
00860001720426Virtual FieldField Virtual IncHPT2023-01-23
00860001720419Virtual FieldField Virtual IncHPT2023-01-23
04049584000040Twinfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2022-12-01
04049584000125Centerfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2022-12-01
04049584019363SmartfieldOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2022-11-30
09349221000040Medmont Automated Perimeter M700 USBMEDMONT INTERNATIONAL PTY LTDHPT2022-09-14
09349221000071Medmont Automated Perimeter DACMEDMONT INTERNATIONAL PTY LTDHPT2022-09-14
07290017803005Foresee Home™NOTAL VISION LTDHPT2021-04-01
06973211070541PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-08-28
06973211070558PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-08-28
06973211070534PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-07-02
06973211070565PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-07-02
06973211070572PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-07-02
06973211070589PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-07-02
06973211070596PerimeterCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHPT2020-07-02