DeviceClearance

Product code SBN— Ophthalmic

VERVE

Classification name
Digital Therapy Device For Convergence Insufficiency
Device class
Class 1
Regulation
21 CFR 886.1290
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency”

— U.S. Food and Drug Administration, device classification record for product code SBN under 21 CFR 886.1290, via openFDA

Market context for product code SBN

FDA has cleared 1 device under product code SBN, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SBN

Recent clearances under product code SBN

Data sourced from openFDA. This site is unofficial and independent of the FDA.