Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Fotona D.O.O.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories4
Latest FDA decision2025-03-27
TypeNumberDevice NameCodeDateActions
510(k) K241785 StarFormer (M008-3T)QPL2025-03-27 View
510(k) K242202 LightWalker Laser System FamilyGEX2024-08-23 View
510(k) K234061 StarFormerKPI2024-07-01 View
510(k) K221274 StarFormer, TightWaveIPF2023-09-29 View
510(k) K223540 AvalancheLase FamilyGEX2023-01-19 View
510(k) K221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)GEX2022-10-12 View
510(k) K213267 Dynamis Pro FamilyGEX2022-09-08 View
510(k) K202991 Fotona XPulse Pro Laser PlatformGEX2021-06-22 View
510(k) K202985 LightWalker Laser System FamilyGEX2021-03-19 View
510(k) K202172 StarWalkerGEX2020-11-19 View
510(k) K193656 SkyPulseGEX2020-03-27 View
510(k) K193661 LightWalker Laser System FamilyGEX2020-03-25 View
510(k) K191554 LightWalker Laser System FamilyGEX2019-08-30 View
510(k) K182088 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroGEX2018-10-31 View
510(k) K172819 LightWalker Laser System FamilyGEX2017-12-01 View
510(k) K171227 StarWalkerGEX2017-08-18 View
↑