Home / 510(k) Clearances / K221659

510(k) K221659

Luminopia One by Luminopia, Inc. — Product Code QQU

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.

Other clearances by Luminopia, Inc.

  • K243819 — Luminopia (April 9, 2025)
  • K233720 — Luminopia (August 8, 2024)
  • DEN210005 — Luminopia One (October 20, 2021)

Other clearances for product code QQU

  • K243819 — Luminopia (April 9, 2025)
  • K233720 — Luminopia (August 8, 2024)
  • K221375 — CureSight-CS100 (September 29, 2022)
  • DEN210005 — Luminopia One (October 20, 2021)