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510(k) DEN210005

Luminopia One by Luminopia, Inc. — Product Code QQU

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 20, 2021
Date Received
March 1, 2021
Clearance Type
Direct
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)
  • K221659 — Luminopia One (November 4, 2022)

Other clearances for product code QQU

  • K243819 — Luminopia (April 9, 2025)
  • K233720 — Luminopia (August 8, 2024)
  • K221659 — Luminopia One (November 4, 2022)
  • K221375 — CureSight-CS100 (September 29, 2022)