QQU
5 FDA 510(k) clearances · Product code
149 daysmedian time to decision
261 days90th percentile
5clearances measured
FDA profile
- Official device name
- Digital Therapy Device For Amblyopia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5500
- Medical specialty
- Ophthalmic
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Luminopia (K243819) | Luminopia, Inc. | 2025-04-09 |
| Luminopia (K233720) | Luminopia, Inc. | 2024-08-08 |
| Luminopia One (K221659) | Luminopia, Inc. | 2022-11-04 |
| CureSight-CS100 (K221375) | Novasight , Ltd. | 2022-09-29 |
| Luminopia One (DEN210005) | Luminopia, Inc. | 2021-10-20 |
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Every clearance here is in the API, with alerts when new ones post.