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FDA PRODUCT CODE · CLASS II

QQU — Digital Therapy Device For Amblyopia

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 886.5500
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K243819Luminopia, Inc. · 510k2025-04-09

Related on SPEQ

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Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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