510(k) K250307
- Device
- Visualase V2 MRI-guided Laser Ablation System (9736422)
- Applicant
- Medtronic Navigation
- 510(k) number
- K250307
- Product code
- ONO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-29
- Date received
- 2025-02-03
- Regulation
- 878.4810
- Classification name
- Neurosurgical Laser With Mr Thermography
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharon McDermott
- Address
- 200 Medtronic Dr. Lafayette CO US 80026 80026
FDA Registration Numbers#
- 3012452798
- 1045254
- 3009970070
- 3006849754
- 1723170
- 3018094310
- 2183744
Source Documents#
Other 510(k) Records For Product Code ONO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260976 | NeuroBlate System | Monteris Medical | 2026-04-23 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. | 2026-03-13 |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems, AB | 2025-09-04 |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024-06-04 |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022-09-22 |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022-01-07 |