Fluoptics Sas (A Getinge Group Company} FDA Approvals

0 new drug approvals and 2 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
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)510(k)Apr 17, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 17, 2025
FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)510(k)Dec 15, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Dec 15, 2023