Data / Medical devices / France / Fluoptics SAS
Fluoptics SAS: FDA-registered device maker in GRENOBLE Auvergne-Rhone-Alpes, France, 4 510(k) clearances
Fluoptics SAS is registered with the FDA (registration 3011092264) in GRENOBLE Auvergne-Rhone-Alpes, France. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011092264
- Address
- 44 rue des berges, GRENOBLE Auvergne-Rhone-Alpes, France, 38000
- Owner or operator
- FLUOPTICS SAS (10047454)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 8, 2014
- Registered through
- 2026
- Brand names listed
- FLUOBEAM LM, FLUOBEAM LX, FLUOBEAM LX Red, FLUOCLIP, FluoPod, Fluobeam 800, Fluocart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Confocal Optical Imaging | OWN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Holder, Camera, Surgical | FXR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Parathyroid Autofluorescence Imaging Device | QDG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2025 | K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | QDG | Substantially Equivalent | Fluoptics Sas (A Getinge Group Company} | accessdata.fda.gov |
| December 15, 2023 | K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | QDG | Substantially Equivalent | Fluoptics Sas (A Getinge Group Company) | accessdata.fda.gov |
| July 31, 2019 | K190891 | Fluobeam LX | QDG | Substantially Equivalent | Fluoptics | accessdata.fda.gov |
| May 7, 2014 | K132475 | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM | OWN | Substantially Equivalent | Fluoptics | accessdata.fda.gov |
Compare with other makers
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of Confocal Optical Imaging
- All makers of Holder, Camera, Surgical
- All makers of Table And Attachments, Operating-Room
Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.