K243729 is an FDA 510(k) clearance for the Prismira. This device is classified as a Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder (Class II - Special Controls, product code QFT).
Submitted by Lumos Labs, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 13, 2025, 192 days after receiving the submission on December 3, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5803. A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment..
| 510(k) Number | K243729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2024 |
| Decision Date | June 13, 2025 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QFT - Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5803 |
| Definition | A Digital Therapy Device For Attention Deficit Hyperactivity Disorder (adhd) Is A Software Intended To Provide Therapy For Adhd Or Any Of Its Individual Symptoms As An Adjunct To Clinician Supervised Treatment. |