FDA Registration
Active
🇫🇷 France
FLUOPTICS SAS
Reg #: 3011092264
·
FEI: 3011092264
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- FLUOPTICS SAS
- Registration Number
- 3011092264
- FEI Number
- 3011092264
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 44 rue des berges
- City
- GRENOBLE Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K250455
Owner / Operator
- Firm Name
- FLUOPTICS SAS
- Operator Number
- 10047454
- Address
- 44 rue des berges
- City
- GRENOBLE
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 38000
- Country
- FR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2025-06-27 |
| Parathyroid Autofluorescence Imaging Device | QDG | Class 2 | General, Plastic Surgery | No | 2025-06-27 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2016-12-20 |
| Holder, Camera, Surgical | FXR | Class 1 | General, Plastic Surgery | No | 2020-02-10 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2015-06-17 |
Proprietary Names
FLUOBEAM LM
FLUOBEAM LX
FLUOBEAM LX Red
FluoPod
FLUOCLIP
Fluobeam 800
Fluocart
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device