Clinical Laserthermia Systems AB
Lund Skane, SE
CLINICAL LASERTHERMIA SYSTEMS AB appears in FDA device records in Lund Skane, SE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Clinical Laserthermia Systems AB between 2015 and 2025. The busiest year on record is 2015, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K214125 | TRANBERG Thermoguide Therapy System | ONO | Substantially Equivalent | |
| K201466 | Tranberg CLS Laser Applicator | GEX | Substantially Equivalent | |
| K163103 | Tranberg CLS Diffusor Laser Fiber | GEX | Substantially Equivalent | |
| K151569 | Tranberg CLS Laser Fiber | GEX | Substantially Equivalent | |
| K142216 | Tranberg CLS Thermal Therapy System | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012452798 | 3012452798 | CLINICAL LASERTHERMIA SYSTEMS AB | Scheelevagen 2, Lund Skane 22381 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1782-2021 | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, 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 | Class II | Terminated | |
| Z-1781-2021 | Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, 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 | Class II | Terminated | |
| Z-1780-2021 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain