510(k) K221375

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 29, 2022

Date Received

May 12, 2022

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Digital Therapy Device For Amblyopia

Device Class

Class II

Regulation Number

886.5500

Review Panel

OP

Submission Type

A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.