QTO · Class I · 21 CFR 886.1150

FDA Product Code QTO: Digital Visual Acuity Test

A Digital Visual Acuity Testing System Is Intended As An Aid In The Assessment Of Visual Acuity In Patients.

Leading manufacturers include Visibly, Inc..

1
Total
1
Cleared
213d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Digital Visual Acuity Test Devices (Product Code QTO)

1 devices
1–1 of 1
Cleared Aug 12, 2022
Visibly Digital Acuity Product
K220090
Visibly, Inc.
Ophthalmic · 213d

About Product Code QTO - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTO since 2022, with 1 receiving FDA clearance (average review time: 213 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.