Clearance Summary
FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) received FDA 510(k) clearance under submission number K250455, sponsored by Fluoptics Sas (A Getinge Group Company}. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-04-17.
- Submission: K250455
- Applicant / Sponsor: Fluoptics Sas (A Getinge Group Company}
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4550
- Decision date: 2025-04-17
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.