Clinical Laserthermia Systems, AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Clinical Laserthermia Systems, AB - FDA 510(k) Cleared Devices
Recent clearances: Mobile Laser Unit (1001-N2), TRANBERG Thermoguide Therapy System, Tranberg CLS Laser Applicator
6
Total
6
Cleared
0
Denied
Clinical Laserthermia Systems, AB has 6 FDA 510(k) cleared medical devices. Based in Lund, SE.
Latest FDA clearance: Sep 2025. Active since 2015. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Clinical Laserthermia Systems, AB Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Omedtech, LLC and Hogan Lovells US LLP.
FDA 510(k) Regulatory Record - Clinical Laserthermia Systems, AB
6 devices
Cleared
Sep 04, 2025
Mobile Laser Unit (1001-N2)
Neurology
129d
Cleared
Sep 22, 2022
TRANBERG Thermoguide Therapy System
Neurology
266d
Cleared
Mar 26, 2021
Tranberg CLS Laser Applicator
General & Plastic Surgery
297d
Cleared
Mar 23, 2017
Tranberg CLS Diffusor Laser Fiber
General & Plastic Surgery
136d
Cleared
Feb 12, 2016
Tranberg CLS Laser Fiber
General & Plastic Surgery
247d
Cleared
Apr 21, 2015
Tranberg CLS Thermal Therapy System
General & Plastic Surgery
252d