# ONO: Neurosurgical Laser With Mr Thermography

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 129 days (middle half 115–255)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2022: 2
- 2024: 1
- 2025: 2
- 2026: 3

## Most-cited predicates
- K240877: Monteris Medical NeuroBlate System (2024), cited by 4
- K211269: Visualase MRI-Guided Laser Ablation System (SW 3.4) (2022), cited by 3
- K214125: TRANBERG Thermoguide Therapy System (2022), cited by 2
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422) (2025), cited by 1
- K260976: NeuroBlate System (2026), cited by 1

Source page: https://510kreport.com/product-code/ONO
Data by year (CSV): https://510kreport.com/product-code/ONO.csv