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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K252951
Device Name Genesis Sleep
Applicant
Neurofield, Inc.
1836 St.Ate St.
Santa Barbara,  CA  93101
Applicant Contact Nicholas Dogris
Correspondent
Vision28
915 SW Rimrock Way
Suite 201 Pmb 402
Redmond,  OR  97756
Correspondent Contact Tom Renner
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received09/16/2025
Decision Date 12/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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