Tranberg CLS Thermal Therapy System

K142216 is the FDA 510(k) clearance record for Tranberg CLS Thermal Therapy System, a class II device, cleared for Clinical Laserthermia Systems, AB on 2015-04-21 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 6 510(k) clearances for Clinical Laserthermia Systems, AB, from 2015-04-21 to 2025-09-04. As of 2026-09-10, FDA records show no recalls naming K142216.