Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012452798

FEI Number

3012452798

Entity Name

CLINICAL LASERTHERMIA SYSTEMS AB

City/State/Country

Lund Skane, SE

Establishment Address

Scheelevagen 2, Lund Skane 22381, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Clinical Laserthermia Systems AB (Owner Number: 10050452)

Owner / Operator Contact Address

Scheelevagen 2, Lund, SE-M 22381, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163103

PMA Number

N/A

All Registered Proprietary Names

MR Cannula Tranberg CLS Introducer/Trocar MRI Compatible Tranberg CLS Laser Fiber Tranberg CLS Thermal Therapy System TRANBERG Thermoguide Therapy System Tranberg CLS Diffusor Laser Fiber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-11-30
DRC	Trocar	Cardiovascular	Class 2	870.1390	2016-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2016-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-11-18
ONO	Neurosurgical Laser With Mr Thermography	General, Plastic Surgery	Class 2	878.4810	2022-10-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-06-20

Official Correspondent

Lars-Erik Eriksson

US Agent Details

David Makanani Business: OMEDtech Email: dmakanani@omedtech.com Phone: (405) 8260713

Related Public Records

Same Entity

Clinical Laserthermia Systems AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012452798. Last updated year: 2026. Please use registration number 3012452798 when referencing this establishment in official correspondence.