FDA Product Code SBN: Digital Therapy Device For Convergence Insufficiency
A Digital Therapy Device For Convergence Insufficiency Is An Electronic Device That Incorporates Binocular Presentations On Visual Displays To Treat Convergence Insufficiency
Leading manufacturers include Oculomotor Technologies.
1
Total
1
Cleared
267d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Digital Therapy Device For Convergence Insufficiency Devices (Product Code SBN)
1 devices
About Product Code SBN - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBN since 2024, with 1 receiving FDA clearance (average review time: 267 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.