K253391 is an FDA 510(k) clearance for the Visualase Cooled Laser Applicator System (9735559). This device is classified as a Neurosurgical Laser With Mr Thermography (Class II - Special Controls, product code ONO).
Submitted by Medtronic Navigation, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 13, 2026, 164 days after receiving the submission on September 30, 2025.
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 | K253391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 164 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. |