K221659 is an FDA 510(k) clearance 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 Cleared decision on November 4, 2022, 149 days after receiving the submission on June 8, 2022.
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 | K221659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| 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. |