DEN250015 is an FDA 510(k) submission for the Neurolyser XR (NXR100). This device is classified as a High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation (Class II - Special Controls, product code SGN).
Submitted by Fusmobile, Inc. (Alpharetta, US). The FDA issued a Not Cleared (DENG) decision on November 14, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4420. A High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation Is A Device That Transmits Ultrasound Energy To Produce Thermal Lesions In A Defined, Targeted Volume Of Peripheral Nervous Tissue Through Acoustic Coupling..
| 510(k) Number | DEN250015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 25, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 203 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SGN - High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4420 |
| Definition | A High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation Is A Device That Transmits Ultrasound Energy To Produce Thermal Lesions In A Defined, Targeted Volume Of Peripheral Nervous Tissue Through Acoustic Coupling. |