SBN

Digital Therapy Device For Convergence Insufficiency

Product code

SBN

Device name

Digital Therapy Device For Convergence Insufficiency

Device class

Class 1

21 CFR

21 CFR 886.1290

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-06-13.

1 summaries are archived here for direct download.