510(k) K221659
K221659 is an FDA 510(k) premarket notification submitted by Luminopia, Inc. for the device "Luminopia One". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code QQU (Digital Therapy Device For Amblyopia), a Class II device regulated under 21 CFR 886.5500. Luminopia, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2022
- Date Received
- June 8, 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.