Luminopia

GUDID 00860007887116

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

Luminopia, Inc.

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• Primary Device ID: 00860007887116
• NIH Device Record Key: 5e1693b2-b8ce-4d12-8652-a42309e996b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminopia
• Version Model Number: 2.0
• Company DUNS: 080293821
• Company Name: Luminopia, Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00860007887116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210005

FDA Product Code

• QQU: Digital Therapy Device For Amblyopia

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [Luminopia]

• 00860007887123: Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
• 00860007887116: Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
• 00860007887109: Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day