DEN210005 is an FDA 510(k) submission for the Luminopia One. This device is classified as a Digital Therapy Device For Amblyopia (Class II - Special Controls, product code QQU).
Submitted by Luminopia, Inc. (Cambridge, US). The FDA issued a Not Cleared (DENG) decision on October 20, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5500. 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..
| 510(k) Number | DEN210005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 01, 2021 |
| Decision Date | October 20, 2021 |
| Days to Decision | 233 days |
| Submission Type | Direct |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | QQU - Digital Therapy Device For Amblyopia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5500 |
| 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. |