Luminopia

Basic Information

• Brand Name: Luminopia
• Primary DI: 00860007887123
• Version / Model: 2.0
• Company Name: Luminopia, Inc.
• Labeler DUNS: 080293821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 44505ee1-7c20-4efa-8f5c-f77a5cbe3831

Device Description

Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia

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: Yes
• 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
QQU	Digital Therapy Device For Amblyopia	Ophthalmic	886.5500	2

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	00860007887123	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN210005	000