Company ยท SI
Fotona D.O.O.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 2026 | K252723 | Dynamis Pro Family Fotona D.O.O., SI | GEX |
| Mar 27, 2025 | K241785 | StarFormer (M008-3T) Fotona D.O.O., SI | QPL |
| Aug 23, 2024 | K242202 | LightWalker Laser System Family Fotona D.O.O., SI | GEX |
| Jul 1, 2024 | K234061 | StarFormer Fotona D.O.O., SI | KPI |
| Sep 29, 2023 | K221274 | StarFormer, TightWave Fotona D.O.O., SI | IPF |
| Jan 19, 2023 | K223540 | AvalancheLase Family Fotona D.O.O., SI | GEX |
| Oct 12, 2022 | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) Fotona D.O.O., SI | GEX |
| Sep 8, 2022 | K213267 | Dynamis Pro Family Fotona D.O.O., SI | GEX |
| Jun 22, 2021 | K202991 | Fotona XPulse Pro Laser Platform Fotona D.O.O., SI | GEX |
| Mar 19, 2021 | K202985 | LightWalker Laser System Family Fotona D.O.O., SI | GEX |
| Nov 19, 2020 | K202172 | StarWalker Fotona D.O.O., SI | GEX |
| Mar 27, 2020 | K193656 | SkyPulse Fotona D.O.O., SI | GEX |
| Mar 25, 2020 | K193661 | LightWalker Laser System Family Fotona D.O.O., SI | GEX |
| Aug 30, 2019 | K191554 | LightWalker Laser System Family Fotona D.O.O., SI | GEX |
| Oct 31, 2018 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro Fotona D.O.O., SI | GEX |
| Dec 1, 2017 | K172819 | LightWalker Laser System Family Fotona D.O.O., SI | GEX |
| Aug 18, 2017 | K171227 | StarWalker Fotona D.O.O., SI | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||