Home GUDID 00860007887109 Luminopia
Primary DI 00860007887109
Brand Luminopia
Company Luminopia, Inc.
Model 2.0
Device description Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Published 2022-09-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QQU Digital Therapy Device For Amblyopia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QQU Digital Therapy Device For Amblyopia Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860007887109 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860007887109 00860007887109 860007887109 0860007887109
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 080293821 Device count 1 Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes#