DeviceClearance

Product code QQU— Ophthalmic

Luminopia

Classification name
Digital Therapy Device For Amblyopia
Device class
Class 2
Regulation
21 CFR 886.5500
Advisory panel
Ophthalmic
Total cleared
5
First cleared
Most recent

FDA classification definition

“A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.”

— U.S. Food and Drug Administration, device classification record for product code QQU under 21 CFR 886.5500, via openFDA

Market context for product code QQU

FDA has cleared 5 devices under product code QQU between 2021 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QQU

Recent clearances under product code QQU

Data sourced from openFDA. This site is unofficial and independent of the FDA.