FLUOBEAM® LX Red— 510(k) K230898
Substantially EquivalentFluoptics Sas
FDA 510(k) clearance K230898 for FLUOBEAM® LX Red, Substantially Equivalent on 2023-07-28. Applicant: Fluoptics Sas. Device class: 2.
Clearance details
- Applicant
- Fluoptics Sas
- Product code
- Code QDG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Grenoble, FR
Recent devices under product code QDG
view all- K253303 — Dendrite Imaging System
- K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- K190891 — Fluobeam LX
- DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Data sourced from openFDA. This site is unofficial and independent of the FDA.