Clearance Summary
Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) received FDA 510(k) clearance under submission number K240297, sponsored by Us Medical Innovations, LLC. 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 2024-05-03.
- Submission: K240297
- Applicant / Sponsor: Us Medical Innovations, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2024-05-03
Classification & Regulation
This clearance is catalogued under FDA product code OAB and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.