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.
FDA 510(k) Cleared Digital Therapy Device For Convergence Insufficiency Devices (Product Code SBN)
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBN devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →