Clearance Summary
FLUOBEAM® LX Red received FDA 510(k) clearance under submission number K230898, sponsored by Fluoptics Sas. 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 2023-07-28.
- Submission: K230898
- Applicant / Sponsor: Fluoptics Sas
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4550
- Decision date: 2023-07-28
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.