Vision Restoration Therapy

Basic Information

• Brand Name: Vision Restoration Therapy
• Primary DI: 00860010599709
• Version / Model: VRT 7.0
• Company Name: Novavision, Inc.
• Labeler DUNS: 078373323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-03
• Public Version: 1
• Public Version Date: 2023-07-11
• Public Version Status: New
• Public Device Record Key: 2d57b0ee-0cac-4851-9762-696a39adddf7

Device Description

VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	886.1605	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64313	Vision training software	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010599709	GS1

Premarket Submissions

Submission Number	Supplement Number
K023623	000