K211269 is an FDA 510(k) clearance for the Visualase MRI-Guided Laser Ablation System (SW 3.4). This device is classified as a Neurosurgical Laser With Mr Thermography (Class II - Special Controls, product code ONO).
Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on January 7, 2022, 255 days after receiving the submission on April 27, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 878.4810. 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..
| 510(k) Number | K211269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ONO — Neurosurgical Laser With Mr Thermography |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| 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. |