This page includes the latest FDA filings for Fotona D O O. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9613462 |
| FEI Number | 1000597018 |
| Name | FOTONA D.O.O. |
| Owner & Operator | FOTONA D.O.O. |
| Contact Address | STEGNE 7 LJUBLJANA SI-061 Ljubljana (urbane commune) 1000 SI |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | STEGNE 7, LJUBLJANA Ljubljana (urbane commune), 1000 SI |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| FOTONA d.o.o. | LightWalker Max | 2025-07-21 |
| FOTONA d.o.o. | QuantumStar, StarFormer | 2025-06-20 |
| FOTONA d.o.o. | SkyPulse | 2024-10-14 |
| FOTONA d.o.o. | SkyPulse | 2024-10-14 |
| FOTONA d.o.o. | AvalancheLase | 2024-09-30 |
| FOTONA d.o.o. | LightWalker ST-E ADVANCED | 2024-09-27 |
| FOTONA d.o.o. | LightWalker ST-E PRO | 2024-09-27 |
| FOTONA d.o.o. | LightWalker AT S | 2024-09-27 |
| FOTONA d.o.o. | TimeWalker ST-E | 2024-09-27 |
| FOTONA d.o.o. | TimeWalker AT | 2024-09-27 |
| FOTONA d.o.o. | XPulse | 2024-09-23 |
| FOTONA d.o.o. | StarFormer | 2024-08-07 |
| FOTONA d.o.o. | AvalancheLase | 2023-03-15 |
| FOTONA d.o.o. | AvalancheLase | 2023-03-15 |
Fotona D.o.o. | Fotona XPulse Laser System Family (XPulse 1064 Nm, XPulse 810 Nm, XPulse 980 Nm) | 2022-10-12 |
Fotona D.o.o. | Dynamis Pro Family | 2022-09-08 |
| FOTONA d.o.o. | TimeWalker ST-E | 2021-12-09 |
| FOTONA d.o.o. | TimeWalker AT | 2021-12-09 |
| FOTONA d.o.o. | StarWalker | 2021-08-24 |
| FOTONA d.o.o. | StarWalker | 2021-08-24 |
| FOTONA d.o.o. | Fotona QX Max | 2021-08-24 |
Fotona D.o.o. | LightWalker Laser System Family | 2021-03-19 |
| FOTONA d.o.o. | StarWalker | 2021-02-05 |
| FOTONA d.o.o. | SkyPulse | 2020-07-01 |
| FOTONA d.o.o. | SkyPulse | 2020-07-01 |
FOTONA D.O.O. | SkyPulse Laser Platform | 2020-03-30 |
Fotona D.o.o. | SkyPulse | 2020-03-27 |
FOTONA D.O.O. | LightWalker Laser System Family | 2020-03-26 |
Fotona D.o.o. | LightWalker Laser System Family | 2020-03-25 |
| FOTONA d.o.o. | LightWalker ST-E PRO | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker ST-E ADVANCED | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker DT ADVANCED | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker AT S | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker ST-E STAND | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker DT STAND | 2020-02-06 |
| FOTONA d.o.o. | LightWalker ST-E ADVANCED | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker ST-E | 2020-02-06 |
| FOTONA d.o.o. | Fotona XP-2 Focus | 2020-02-06 |
| FOTONA d.o.o. | Fotona XP Focus | 2020-02-06 |
| FOTONA d.o.o. | XP Spectro | 2020-02-06 |
| FOTONA d.o.o. | SP Spectro | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker AT | 2020-02-06 |
| FOTONA d.o.o. | Fotona XP Focus | 2020-02-06 |
| FOTONA d.o.o. | Fotona XP Max | 2020-02-06 |
| FOTONA d.o.o. | XS Dynamis | 2020-02-06 |
| FOTONA d.o.o. | XP Dynamis | 2020-02-06 |
| FOTONA d.o.o. | SP Dynamis | 2020-02-06 |
| FOTONA d.o.o. | Lightwalker DT | 2020-02-06 |
FOTONA D.O.O. | LightWalker Laser System Family | 2019-09-27 |
FOTONA D.O.O. | LightWalker Laser System Family | 2019-09-27 |
FOTONA D.O.O. | LightWalker Laser System Family | 2019-09-27 |
FOTONA D.O.O. | LightWalker Laser System Family | 2019-09-27 |
FOTONA D.O.O. | Dynamis Pro Family | 2018-11-23 |
Fotona D.o.o. | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | 2018-10-31 |
FOTONA D.O.O. | Fotona Lightwalker Laser System Family | 2017-12-08 |
Fotona D.o.o. | LightWalker Laser System Family | 2017-12-01 |
FOTONA D.O.O. | StarWalker | 2017-08-23 |
Fotona D.o.o. | StarWalker | 2017-08-18 |
FOTONA D.O.O. | Fotona Dynamis | 2015-04-24 |
FOTONA D.O.O. | Fotona Dynamis | 2015-04-24 |
FOTONA D.O.O. | Fotona XP Nd:YAG Laser System Family | 2013-11-08 |
FOTONA D.O.O. | Fotona XP Nd:YAG Laser System Family | 2013-11-08 |
FOTONA D.O.O. | Fotona XP Plus Nd:YAG Family | 2011-12-07 |
FOTONA D.O.O. | Fotona XP Nd:YAG Laser System Family | 2011-10-10 |