CLINICAL LASERTHERMIA SYSTEMS AB
FDA Regulatory Profile
CLINICAL LASERTHERMIA SYSTEMS AB appears in FDA public data with 3 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1781-2021, Class II) was initiated on April 1, 2021. Its most recent 510(k) clearance was granted on September 4, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1781-2021 | Class II | Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with t | April 1, 2021 |
| Z-1780-2021 | Class II | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR I | April 1, 2021 |
| Z-1782-2021 | Class II | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Ster | April 1, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, | September 4, 2025 |
| K214125 | TRANBERG Thermoguide Therapy System | September 22, 2022 |
| K201466 | Tranberg CLS Laser Applicator | March 26, 2021 |
| K163103 | Tranberg CLS Diffusor Laser Fiber | March 23, 2017 |
| K151569 | Tranberg CLS Laser Fiber | February 12, 2016 |
| K142216 | Tranberg CLS Thermal Therapy System | April 21, 2015 |