K251298 is an FDA 510(k) clearance for the Mobile Laser Unit (1001-N2). This device is classified as a Neurosurgical Laser With Mr Thermography (Class II - Special Controls, product code ONO).
Submitted by Clinical Laserthermia Systems, AB (Lund, SE). The FDA issued a Cleared decision on September 4, 2025, 129 days after receiving the submission on April 28, 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 | K251298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2025 |
| Decision Date | September 04, 2025 |
| Days to Decision | 129 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. |