# DEN250015: Neurolyser XR (NXR100)

- Pathway: De Novo (Direct)
- Applicant: Fusmobile, Inc.
- Decided: Nov 14, 2025 after 203 days
- Product code: SGN (High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 882.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Neurolyser XR is indicated for the thermal ablation (neurolysis) of the medial branch nerve of the lumbar facet joint(s) (L1 to L5) for the treatment of chronic, facet-mediated low back pain of at least 6 months duration and a confirmed diagnosis based on positive response to lumbar branch block or denervation.

Source page: https://510kreport.com/device/DEN250015
Methodology: https://510kreport.com/methodology