510(k) K233720
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2024
- Date Received
- November 21, 2023
- 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.