Foresee Home™ 901F001

GUDID 07290017803005

NOTAL VISION LTD

Macular pigment analyser

• Primary Device ID: 07290017803005
• NIH Device Record Key: 7d723950-776b-40cb-8892-e31e5ee44e8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foresee Home™
• Version Model Number: V2
• Catalog Number: 901F001
• Company DUNS: 532596533
• Company Name: NOTAL VISION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017803005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091579

FDA Product Code

• HPT: Perimeter, Automatic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

Devices Manufactured by NOTAL VISION LTD

• 07290017803012 - SCANLY: 2024-06-26 Home Monitoring Ophthalmic Optical Coherence Tomography (OCT) Imaging Device
• 07290017803005 - Foresee Home™: 2021-04-09
• 07290017803005 - Foresee Home™: 2021-04-09