FLUOBEAM® LX Red
FDA 510(k) clearance K230898 · decided 2023-07-28
Clearance details
- K-number
- K230898
- Device name
- FLUOBEAM® LX Red
- Applicant
- Fluoptics Sas
- Decision
- Substantially Equivalent
- Date received
- 2023-03-31
- Decision date
- 2023-07-28
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- QDG
- Device class
- 2
- Regulation number
- 878.4550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Grenoble, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dendrite Imaging System (K253303) | Dendrite Imaging, Inc. | 2025-11-28 |
| FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 |
| FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (K233564) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 |
| Fluobeam LX (K190891) | Fluoptics | 2019-07-31 |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) | Fluoptics | 2018-11-02 |
Recalls involving this device
No recalls on record reference this clearance.