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
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Digital Visual Acuity Test Devices (Product Code QTO)
1 devices
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QTO devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →