Cleared Traditional

K214125 - TRANBERG Thermoguide Therapy System (FDA 510(k) Clearance)

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

K214125 · Clinical Laserthermia Systems, AB · Neurology device
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Sep 2022
Decision
266d
Days
Class 2
Risk

K214125 is an FDA 510(k) clearance for the TRANBERG Thermoguide Therapy System. 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 22, 2022 after a review of 266 days - an extended review cycle.

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 K214125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date September 22, 2022
Days to Decision 266 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
118d slower than avg
Panel avg: 148d · This submission: 266d
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

Hogan Lovells US LLP
John Smith

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.

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