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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K251243
Device Name OneRF Trigeminal Nerve Radiofrequency Probes
Applicant
Neuroone Medical Technologies Corp.
7599 Anagram Dr.
Eden Prairie,  MN  55344
Applicant Contact Debra Kridner
Correspondent
Neuroone Medical Technologies Corp.
7599 Anagram Dr.
Eden Prairie,  MN  55344
Correspondent Contact Debra Kridner
Regulation Number882.4725
Classification Product Code
GXI  
Date Received04/22/2025
Decision Date 08/15/2025
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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