Medical Device Manufacturer · SI , Ljubljana

Fotona D.O.O. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2017

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fotona D.O.O. Physical Medicine ✕

2 devices

1-2 of 2

Cleared Mar 27, 2025

StarFormer (M008-3T)

Physical Medicine · 280d

Cleared Sep 29, 2023

StarFormer, TightWave

Physical Medicine · 515d