K252951 is an FDA 510(k) clearance for the Genesis Sleep. This device is classified as a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II - Special Controls, product code QJQ).
Submitted by Neurofield, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on December 31, 2025, 106 days after receiving the submission on September 16, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5800. To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety.
| 510(k) Number | K252951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2025 |
| Decision Date | December 31, 2025 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QJQ - Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5800 |
| Definition | To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety |