Fotona D.O.O. FDA Approvals

0 new drug approvals and 10 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Dynamis Pro Family510(k)Sep 19, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 19, 2026
StarFormer (M008-3T)510(k)Mar 27, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 27, 2025
LightWalker Laser System Family510(k)Aug 23, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Aug 23, 2024
StarFormer510(k)Jul 1, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
StarFormer, TightWave510(k)Sep 29, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Sep 29, 2023
AvalancheLase Family510(k)Jan 19, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 19, 2023
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)510(k)Oct 12, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
Dynamis Pro Family510(k)Sep 8, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 8, 2022
Fotona XPulse Pro Laser Platform510(k)Jun 22, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 22, 2021
LightWalker Laser System Family510(k)Mar 19, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 19, 2021