Cleared Traditional

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 · Neurology

Sep 2025

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K251298 is an FDA 510(k) clearance for the Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6), 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 review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K251298 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.