Product code QQU

Device name

Digital Therapy Device For Amblyopia

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5500

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset