FDA.reportPublic FDA data

Vision Restoration Therapy

Primary DI
00860010599709
Brand
Vision Restoration Therapy
Company
Novavision, Inc.
Model
VRT 7.0
Device description
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023623000NOVAVISION, MODEL 2.0Novavision, Inc.2003-04-22HPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010599709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010599709008600105997098600105997090860010599709

GMDN Terms#

Term, Definition table
TermDefinition
Vision training softwareA patient-interactive software package intended to use visual images (e.g., Gabor patch) to help improve vision based on noninvasive perceptual learning therapy (neuro-vision therapy), typically in patients with amblyopia, or who use corrective eyewear, or following ophthalmic surgery. It is intended to be used in the home under clinical guidance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078373323
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010599716NeuroEyeCoachNEC 2.002023-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975449020015SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
06975449020053SYLChongQing SS Medical Equipments Co., LtdHPT2026-05-14
06975449020060S4OPTIKChongQing SS Medical Equipments Co., LtdHPT2026-05-14
04049584037251Twinfield 3OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2026-01-14
00860011691761Radius InspireRadiusXR, Inc.HPT2025-09-22
G617RVF2001RetinaLogikRetinalogik Inc.HPT2025-03-07
00860010709719Virtual Eye PROVirtual Vision HealthHPT2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHPT2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHPT2024-12-16
G617RVF1001RetinaLogikRetinalogik Inc.HPT2024-12-02
00860010709788Virtual Eye SoftwareVirtual Vision HealthHPT2024-11-27
07649990085074VisionOnePeriVision SAHPT2024-10-14
00860010709757Virtual Eye SoftwareVirtual Vision HealthHPT2024-08-20
04582275270075NAKONAN MEDICAL USA, INC.HPT2024-08-02
00860010709740Virtual Eye SoftwareVirtual Vision HealthHPT2024-05-07
07649990085036VisionOnePeriVision SAHPT2024-02-28
00860010709733Virtual Eye SoftwareVirtual Vision HealthHPT2024-02-27
00860001720433Virtual FieldVirtual Field, Inc.HPT2023-11-08
00853569007108PalmScan VF2000Micro Medical Devices, Inc.HPT2023-08-16
00853569007122PalmScan DA2000Micro Medical Devices, Inc.HPT2023-08-16
04573277310111imovifaCREWT MEDICAL SYSTEMS, INC.HPT2023-06-16
04987669101544MICROPERIMETERNIDEK CO.,LTD.HPT2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.HPT2023-06-12
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 FieldVirtual Field, Inc.HPT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HPT2023-01-23
04049584000040Twinfield 2OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHPT2022-12-01