# Clinical Laserthermia Systems, AB

- Location (FDA's records): Lund, SE
- FDA decisions: 6 (2015–2025): 6 510(k) clearances
- Product codes: GEX (4), ONO (2)
- 510(k) review time since 2016: median 247 days, against 114 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biotex, Inc.: 2 (https://510kreport.com/company/biotex)
- Monteris Medical,: 1 (https://510kreport.com/company/monteris-medical)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Avenda Health, Inc.: 1 (https://510kreport.com/company/avenda-health)
- Monteris Medical,: 1 (https://510kreport.com/company/monteris-medical)

## Its most-cited devices
- K214125: TRANBERG Thermoguide Therapy System (2022), cited by 2
- K142216: Tranberg CLS Thermal Therapy System (2015), cited by 1
- K151569: Tranberg CLS Laser Fiber (2016), cited by 1
- K163103: Tranberg CLS Diffusor Laser Fiber (2017), cited by 1

## Recent decisions
- K251298: Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) (Sep 4, 2025)
- K214125: TRANBERG Thermoguide Therapy System (Sep 22, 2022)
- K201466: Tranberg CLS Laser Applicator (Mar 26, 2021)
- K163103: Tranberg CLS Diffusor Laser Fiber (Mar 23, 2017)
- K151569: Tranberg CLS Laser Fiber (Feb 12, 2016)
- K142216: Tranberg CLS Thermal Therapy System (Apr 21, 2015)

Source page: https://510kreport.com/company/clinical-laserthermia-systems