AccessGUDID - DEVICE: Vision Restoration Therapy (00860010599709)

GUDID

Device Identifier (DI) Information

Brand Name: Vision Restoration Therapy
Version or Model: VRT 7.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Novavision, Inc.

Primary DI Number: 00860010599709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078373323 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPT	Perimeter, Automatic, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023623	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d57b0ee-0cac-4851-9762-696a39adddf7
Public Version Date: July 11, 2023
Public Version Number: 1
DI Record Publish Date: July 03, 2023