Fotona D.O.O.
FDA 510(k) & PMA Approved Devices — 16 products
Total Devices16
Categories4
Latest Approval2025-03-27
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K241785 | StarFormer (M008-3T) | QPL | 2025-03-27 | View |
| 510(k) | K242202 | LightWalker Laser System Family | GEX | 2024-08-23 | View |
| 510(k) | K234061 | StarFormer | KPI | 2024-07-01 | View |
| 510(k) | K221274 | StarFormer, TightWave | IPF | 2023-09-29 | View |
| 510(k) | K223540 | AvalancheLase Family | GEX | 2023-01-19 | View |
| 510(k) | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | GEX | 2022-10-12 | View |
| 510(k) | K213267 | Dynamis Pro Family | GEX | 2022-09-08 | View |
| 510(k) | K202991 | Fotona XPulse Pro Laser Platform | GEX | 2021-06-22 | View |
| 510(k) | K202985 | LightWalker Laser System Family | GEX | 2021-03-19 | View |
| 510(k) | K202172 | StarWalker | GEX | 2020-11-19 | View |
| 510(k) | K193656 | SkyPulse | GEX | 2020-03-27 | View |
| 510(k) | K193661 | LightWalker Laser System Family | GEX | 2020-03-25 | View |
| 510(k) | K191554 | LightWalker Laser System Family | GEX | 2019-08-30 | View |
| 510(k) | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | GEX | 2018-10-31 | View |
| 510(k) | K172819 | LightWalker Laser System Family | GEX | 2017-12-01 | View |
| 510(k) | K171227 | StarWalker | GEX | 2017-08-18 | View |
No matching devices.