Cleared Traditional

Genesis Sleep

K252951 · Neurofield, Inc. · Neurology
Dec 2025
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K252951 is an FDA 510(k) clearance for the Genesis Sleep, 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 review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K252951 FDA.gov
FDA Decision Cleared 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

Device Classification

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