FDA product code QQU

Digital Therapy Device For Amblyopia

Ophthalmic·Class 2·21 CFR 886.5500
US regulatory classifications
US Product Code (FDA)
QQU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.5500
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Digital Therapy Device For Amblyopia is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.