ONO — Neurosurgical Laser With Mr Thermography Class II
Classification Details
- Product Code
- ONO
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- NE
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253391 | medtronic navigation | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Appli | March 13, 2026 |
| K251298 | clinical laserthermia systems | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator | September 4, 2025 |
| K250307 | medtronic navigation | Visualase V2 MRI-guided Laser Ablation System (9736422) | May 29, 2025 |
| K240877 | monteris medical | Monteris Medical NeuroBlate System | June 4, 2024 |
| K214125 | clinical laserthermia systems | TRANBERG Thermoguide Therapy System | September 22, 2022 |
| K211269 | medtronic navigation | Visualase MRI-Guided Laser Ablation System (SW 3.4) | January 7, 2022 |