Cleared Traditional

K251298 - Mobile Laser Unit (1001-N2) (FDA 510(k) Clearance)

Also includes:
Thermoguide Workstation (1100-N1) Laser Applicator (4012-N5, 4017-N2, 4017-N4) MR Introducer (4013-N6)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251298 · Clinical Laserthermia Systems, AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
129d
Days
Class 2
Risk

K251298 is an FDA 510(k) clearance for the Mobile Laser Unit (1001-N2). Classified as Neurosurgical Laser With Mr Thermography (product code ONO), Class II - Special Controls.

Submitted by Clinical Laserthermia Systems, AB (Lund, SE). The FDA issued a Cleared decision on September 4, 2025 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 878.4810 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Laserthermia Systems, AB devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 148d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONO Neurosurgical Laser With Mr Thermography
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Omedtech, LLC
David Makanani

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ONO Neurosurgical Laser With Mr Thermography

Devices cleared under the same product code (ONO) and FDA review panel - the closest regulatory comparables to K251298.
NeuroBlate System
K260976 · Monteris Medical, · Apr 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · Medtronic Navigation, Inc. · Mar 2026
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · Medtronic Navigation · May 2025
Monteris Medical NeuroBlate System
K240877 · Monteris Medical, · Jun 2024
TRANBERG Thermoguide Therapy System
K214125 · Clinical Laserthermia Systems, AB · Sep 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · Medtronic Navigation, Inc. · Jan 2022