Cleared Traditional

TRANBERG Thermoguide Therapy System

K214125 · Clinical Laserthermia Systems, AB · Neurology

Sep 2022

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K214125 is an FDA 510(k) clearance for the TRANBERG Thermoguide Therapy System, 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 22, 2022, 266 days after receiving the submission on December 30, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K214125 FDA.gov
FDA Decision	Cleared 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

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.