QQU

Digital Therapy Device For Amblyopia

Product code

QQU

Device name

Digital Therapy Device For Amblyopia

Device class

Class 2

21 CFR

21 CFR 886.5500

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-04-09.

2 summaries are archived here for direct download.