ONO
7 FDA 510(k) clearances · Product code
129 daysmedian time to decision
266 days90th percentile
7clearances measured
FDA profile
- Official device name
- Neurosurgical Laser With Mr Thermography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Medical specialty
- General, Plastic Surgery
- FDA definition
- Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NeuroBlate System (K260976) | Monteris Medical | 2026-04-23 |
| Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (K253391) | Medtronic Navigation, Inc. | 2026-03-13 |
| Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (K251298) | Clinical Laserthermia Systems, AB | 2025-09-04 |
| Visualase V2 MRI-guided Laser Ablation System (9736422) (K250307) | Medtronic Navigation | 2025-05-29 |
| Monteris Medical NeuroBlate System (K240877) | Monteris Medical, | 2024-06-04 |
| TRANBERG Thermoguide Therapy System (K214125) | Clinical Laserthermia Systems, AB | 2022-09-22 |
| Visualase MRI-Guided Laser Ablation System (SW 3.4) (K211269) | Medtronic Navigation, Inc. | 2022-01-07 |
Track ONO automatically
Every clearance here is in the API, with alerts when new ones post.