SBN — Digital Therapy Device For Convergence Insufficiency Class I

FDA Device Classification

Classification Details

Product Code
SBN
Device Class
Class I
Regulation Number
886.1290
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232930oculomotor technologiesVERVEJune 13, 2024