FDA.reportPublic FDA data

Foresee Home™

Primary DI
07290017803005
Brand
Foresee Home™
Company
NOTAL VISION LTD
Model
V2
Catalog number
901F001
Published
2021-04-01
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
K091579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091579000FORESEE HOMENotal Vision , Ltd.2009-12-23HPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017803005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017803005072900178030057290017803005

GMDN Terms#

Term, Definition table
TermDefinition
Macular pigment analyserA mains electricity (AC-powered) computerized device designed for the noninvasive in vivo measurement of macular pigment optical density (MPOD) used in the evaluation of age-related macular degeneration (AMD). It is a portable unit that includes a light-emitting diode (LED) board intended to evaluate a patient who looks down an ocular lens and responds to a flickering spot (heterochromatic flicker photometry); after a series of presentations a value for the MPOD is calculated and displayed. The device may be used in association with dedicated software installed on a personal computer; it may be used in healthcare facilities or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532596533
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017803029SCANLY01.02910-00022025-07-10
07290017803012SCANLY 01.01910-00012024-06-18

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
00860010599709Vision Restoration TherapyNovavision, Inc.HPT2023-07-03
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