Cleared Traditional

OneRF Trigeminal Nerve Radiofrequency Probes

K251243 · Neuroone Medical Technologies Corp. · Neurology
Aug 2025
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K251243 is an FDA 510(k) clearance for the OneRF Trigeminal Nerve Radiofrequency Probes, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on August 15, 2025, 115 days after receiving the submission on April 22, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K251243 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2025
Decision Date August 15, 2025
Days to Decision 115 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXI — Probe, Radiofrequency Lesion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4725

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