Company ยท SE
Clinical Laserthermia Systems, AB
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2025 | K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introdu Clinical Laserthermia Systems, AB, SE | ONO |
| Sep 22, 2022 | K214125 | TRANBERG Thermoguide Therapy System Clinical Laserthermia Systems, AB, SE | ONO |
| Mar 26, 2021 | K201466 | Tranberg CLS Laser Applicator Clinical Laserthermia Systems, AB, SE | GEX |
| Mar 23, 2017 | K163103 | Tranberg CLS Diffusor Laser Fiber Clinical Laserthermia Systems, AB, SE | GEX |
| Feb 12, 2016 | K151569 | Tranberg CLS Laser Fiber Clinical Laserthermia Systems, AB, SE | GEX |
| Apr 21, 2015 | K142216 | Tranberg CLS Thermal Therapy System Clinical Laserthermia Systems, AB, SE | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2021 | CLINICAL LASERTHERMIA SYSTEMS AB 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 Terminated |
GEX | K151569 K163103 |
| Apr 1, 2021 | CLINICAL LASERTHERMIA SYSTEMS AB 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 tissu Terminated |
GEA | None listed |
| Apr 1, 2021 | CLINICAL LASERTHERMIA SYSTEMS AB 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. Terminated |
GAH | None listed |