AccessGUDID - DEVICE: Luminopia (00860007887116)

GUDID

Device Identifier (DI) Information

Brand Name: Luminopia
Version or Model: 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Luminopia, Inc.

Primary DI Number: 00860007887116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080293821 *Terms of Use

Device Description: Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day

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
QQU	Digital Therapy Device For Amblyopia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210005	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: 5e1693b2-b8ce-4d12-8652-a42309e996b8
Public Version Date: September 30, 2022
Public Version Number: 1
DI Record Publish Date: September 22, 2022