Lund, SE · 3 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| ONO | Neurosurgical Laser With Mr Thermography | Class II | General, Plastic Surgery | 2 | 2025-09-04 |
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 1 | 2021-03-26 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-04-01 | Class II | Terminated | Z-1782-2021 | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usa… | — | single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-01 | 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 Intr… | — | single use devices labeled as sterile may not have been adequately sterilized |
| 2021-04-01 | 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 … | — | single use devices labeled as sterile may not have been adequately sterilized |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-04 | K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | ONO | Class II | General, Plastic Surgery |
| 2022-09-22 | K214125 | TRANBERG Thermoguide Therapy System | ONO | Class II | General, Plastic Surgery |
| 2021-03-26 | K201466 | Tranberg CLS Laser Applicator | GEX | Class II | General, Plastic Surgery |