Visualase MRI-Guided Laser Ablation System (SW 3.4)
FDA 510(k) clearance K211269 · decided 2022-01-07
Clearance details
- K-number
- K211269
- Device name
- Visualase MRI-Guided Laser Ablation System (SW 3.4)
- Applicant
- Medtronic Navigation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-04-27
- Decision date
- 2022-01-07
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- ONO
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. recall (Z-0244-2023) | Medtronic Navigation, Inc. | 2022-11-17 |