510(k) DEN250015

Neurolyser XR (NXR100) by Fusmobile, Inc. — Product Code SGN

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: November 14, 2025
Date Received: April 25, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Device Class: Class II
Regulation Number: 882.4420
Review Panel: NE
Submission Type

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.