The following data is part of a De Novo classification by Luminopia, Inc. with the FDA for Luminopia One.
| DeNovo ID | DEN210005 |
| Device Name: | Luminopia One |
| Classification | Digital Therapy Device For Amblyopia |
| Applicant | Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, MA 02139 |
| Contact | Scott Xiao |
| Product Code | QQU |
| CFR Regulation Number | 886.5500 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ophthalmic |
| Classification Advisory | Ophthalmic |
| Type | Direct |
| Date Received | 2021-03-01 |
| Decision Date | 2021-10-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007887123 | DEN210005 | 000 |
| 00860007887116 | DEN210005 | 000 |
| 00860007887109 | DEN210005 | 000 |