Fluoptics SAS (A Getinge Group Company)
FranceFDA applicant, unverified
- Devices
- 2
What Fluoptics SAS (A Getinge Group Company) makes
Fluoptics Sas manufactures imaging systems designed for intraoperative fluorescence visualization, including the FLUOBEAM® LX and FLUOBEAM® LM series. These devices are used in surgical procedures to enhance tissue differentiation and guide procedures such as tumor resection, lymph node identification, and vascular mapping. The FLUOBEAM® LX Red Imaging System is tailored for specific fluorescence applications in surgery.
The company’s imaging systems fall under FDA Class II devices and are listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is maintained through the FDA’s clearance process. Fluoptics Sas operates as a subsidiary of Getinge Group, based in the US.
Catalogue
- Regimes: CE MDR 510(k) Registry: 510(k)
- Regimes: CE MDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fluoptics Sas (A Getinge Group Company) have in the registry?
The registry currently lists 2 devices for Fluoptics Sas (A Getinge Group Company). Devices recorded under merged duplicate company entries are counted once.
Which registries list Fluoptics Sas (A Getinge Group Company)'s devices?
Among its 2 most recently registered devices, Fluoptics Sas (A Getinge Group Company) has devices listed in FDA 510(k) (2 devices).
What risk classes do Fluoptics Sas (A Getinge Group Company)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fluoptics Sas (A Getinge Group Company)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fluoptics Sas (A Getinge Group Company) in the registry?
The most recently registered devices listed for Fluoptics Sas (A Getinge Group Company) include FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) and FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM).