Data / Medical devices / Sweden / Clinical Laserthermia Systems AB

Clinical Laserthermia Systems AB: FDA-registered device maker in Lund Skane, Sweden, 6 510(k) clearances

Name: Clinical Laserthermia Systems AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Clinical Laserthermia Systems AB is registered with the FDA (registration 3012452798) in Lund Skane, Sweden. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 4, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012452798
Address: Scheelevagen 2, Lund Skane, Sweden, 22381
Owner or operator: Clinical Laserthermia Systems AB (10050452)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed: November 18, 2015
Registered through: 2026
Brand names listed: MR Cannula, MR Stylet, TRANBERG Thermoguide Therapy System, Tranberg CLS Diffusor Laser Fiber, Tranberg CLS Introducer/Trocar MRI Compatible, Tranberg CLS Laser Applicator, Tranberg CLS Laser Fiber, Tranberg CLS Thermal Therapy System

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov
Neurosurgical Laser With Mr Thermography	ONO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov
Trocar	DRC	2	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 4, 2025	K251298	Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)	ONO	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov
September 22, 2022	K214125	TRANBERG Thermoguide Therapy System	ONO	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov
March 26, 2021	K201466	Tranberg CLS Laser Applicator	GEX	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov
March 23, 2017	K163103	Tranberg CLS Diffusor Laser Fiber	GEX	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov
February 12, 2016	K151569	Tranberg CLS Laser Fiber	GEX	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov
April 21, 2015	K142216	Tranberg CLS Thermal Therapy System	GEX	Substantially Equivalent	Clinical Laserthermia Systems, AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 1, 2021	87808	Class II	Terminated	Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.	single use devices labeled as sterile may not have been adequately sterilized	accessdata.fda.gov

Compare with other makers

Updated September 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.