510(k) K251298
K251298 is an FDA 510(k) premarket notification submitted by Clinical Laserthermia Systems, AB for the device "Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code ONO (Neurosurgical Laser With Mr Thermography), a Class II device regulated under 21 CFR 878.4810. Clinical Laserthermia Systems, AB has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2025
- Date Received
- April 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Laser With Mr Thermography
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- NE
- Submission Type
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.