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Clinical Laserthermia Systems, AB

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest FDA decision2025-09-04
TypeNumberDevice NameCodeDateActions
510(k) K251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)ONO2025-09-04 View
510(k) K214125 TRANBERG Thermoguide Therapy SystemONO2022-09-22 View
510(k) K201466 Tranberg CLS Laser ApplicatorGEX2021-03-26 View
510(k) K163103 Tranberg CLS Diffusor Laser FiberGEX2017-03-23 View
510(k) K151569 Tranberg CLS Laser FiberGEX2016-02-12 View