Ljubljana, SI · 13 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 10 | 2026-09-19 |
| QPL | Electromagnetic Stimulator, Pain Relief | Class II | Neurology | 1 | 2025-03-27 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Class II | Gastroenterology, Urology | 1 | 2024-07-01 |
| IPF | Stimulator, Muscle, Powered | Class II | Physical Medicine | 1 | 2023-09-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-19 | K252723 | Dynamis Pro Family | GEX | Class II | General, Plastic Surgery |
| 2025-03-27 | K241785 | StarFormer (M008-3T) | QPL | Class II | Neurology |
| 2024-08-23 | K242202 | LightWalker Laser System Family | GEX | Class II | General, Plastic Surgery |
| 2024-07-01 | K234061 | StarFormer | KPI | Class II | Gastroenterology, Urology |
| 2023-09-29 | K221274 | StarFormer, TightWave | IPF | Class II | Physical Medicine |
| 2023-01-19 | K223540 | AvalancheLase Family | GEX | Class II | General, Plastic Surgery |
| 2022-10-12 | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | GEX | Class II | General, Plastic Surgery |
| 2022-09-08 | K213267 | Dynamis Pro Family | GEX | Class II | General, Plastic Surgery |
| 2021-06-22 | K202991 | Fotona XPulse Pro Laser Platform | GEX | Class II | General, Plastic Surgery |
| 2021-03-19 | K202985 | LightWalker Laser System Family | GEX | Class II | General, Plastic Surgery |
| 2020-11-19 | K202172 | StarWalker | GEX | Class II | General, Plastic Surgery |
| 2020-03-27 | K193656 | SkyPulse | GEX | Class II | General, Plastic Surgery |
| 2020-03-25 | K193661 | LightWalker Laser System Family | GEX | Class II | General, Plastic Surgery |