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# NeuroOne’s Trigeminal Nerve Ablation Cleared
- URL: https://www.fdaweb.com/neuroones-trigeminal-nerve-ablation-cleared/
- Published: 2025-08-19T12:00:00.000Z
- Updated: 2026-09-14T15:19:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159716

FDA has cleared a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for treating pain, or for lesioning nerve tissue for functional neurosurgical procedures. “This clearance leverages the company’s proprietary OneRF Ablation System RF generator platform for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually,” the company says. The trigeminal nerve is the main sensory nerve in the face associated with triggering excruciating pain for this condition.

Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression, radiosurgery, or other percutaneous techniques, the company says. The OneRF device delivers targeted radiofrequency (RF) energy to ablate trigeminal nerve fibers, interrupting pain signaling, it adds. It features a multi-contact RF probe that allows for both precise localization and tailored ablation of the pain-conducting nerve tissue.