Product areas
FDA product code distribution
Fotona D.O.O.
Country / Region:Slovenia (SI)
510(k) submissions
13
Filtered: GEX
Latest clearance
2024-08-23
Product codes
1
GEX
510(k) submissions
13 total · filtered by GEX
Showing 1–13
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K242202 | LightWalker Laser System Family | GEX | Class 2 | 2024-08-23 |
| K223540 | AvalancheLase Family | GEX | Class 2 | 2023-01-19 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | GEX | Class 2 | 2022-10-12 |
| K213267 | Dynamis Pro Family | GEX | Class 2 | 2022-09-08 |
| K202991 | Fotona XPulse Pro Laser Platform | GEX | Class 2 | 2021-06-22 |
| K202985 | LightWalker Laser System Family | GEX | Class 2 | 2021-03-19 |
| K202172 | StarWalker | GEX | Class 2 | 2020-11-19 |
| K193656 | SkyPulse | GEX | Class 2 | 2020-03-27 |
| K193661 | LightWalker Laser System Family | GEX | Class 2 | 2020-03-25 |
| K191554 | LightWalker Laser System Family | GEX | Class 2 | 2019-08-30 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | GEX | Class 2 | 2018-10-31 |
| K172819 | LightWalker Laser System Family | GEX | Class 2 | 2017-12-01 |
| K171227 | StarWalker | GEX | Class 2 | 2017-08-18 |
Company profile
- Canonical name
- Fotona D.O.O.
- Country / Region
- Slovenia(SI)
- Address
- Stegne 7 Ljubljana, SI SI-1000
Predicate manufacturers
Companies whose devices this company cited as predicates
Citing manufacturers
Companies that cited this company's devices as predicates
8 manufacturers
- 16
- 2
- 2
- 1
- 1
- 1
- 1
- 1