Clearance Summary
FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) received FDA 510(k) clearance under submission number K233564, sponsored by Fluoptics Sas (A Getinge Group Company). The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-12-15.
- Submission: K233564
- Applicant / Sponsor: Fluoptics Sas (A Getinge Group Company)
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4550
- Decision date: 2023-12-15
Classification & Regulation
This clearance is catalogued under FDA product code QDG and 21 CFR 878.4550, within the General, Plastic Surgery review panel as a Class II device.