FDA Product Code
FDA Product Code QQU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.5500
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243819 | Luminopia | Luminopia, Inc. | 2025-04-09 | Traditional | PDF ↗ |
| K233720 | Luminopia | Luminopia, Inc. | 2024-08-08 | Traditional | PDF ↗ |
| K221659 | Luminopia One | Luminopia, Inc. | 2022-11-04 | Traditional | PDF ↗ |
| K221375 | CureSight-CS100 | Novasight , Ltd. | 2022-09-29 | Traditional | PDF ↗ |
| DEN210005 | Luminopia One | Luminopia, Inc. | 2021-10-20 | Direct | — |
Product code QQU · Class II · Ophthalmic. Data: openFDA.