Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SloveniaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Fotona with 44 510(k) clearances. The most recent is a 510(k) clearance dated Sep 19, 2026: Dynamis Pro Family.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 19, 2026 | Dynamis Pro FamilyK252723 · GEX | 510(k) clearances |
| Mar 27, 2025 | StarFormer (M008-3T)K241785 · QPL | 510(k) clearances |
| Aug 23, 2024 | LightWalker Laser System FamilyK242202 · GEX | 510(k) clearances |
| Jul 1, 2024 | StarFormerK234061 · KPI | 510(k) clearances |
| Sep 29, 2023 | StarFormer, TightWaveK221274 · IPF | 510(k) clearances |
| Jan 19, 2023 | AvalancheLase FamilyK223540 · GEX | 510(k) clearances |
| Oct 12, 2022 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)K221712 · GEX | 510(k) clearances |
| Sep 8, 2022 | Dynamis Pro FamilyK213267 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
