Digital Therapy Device For Amblyopia

QQU · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5500

Classification

FDA Product Code: QQU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5500
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown