Clearance Summary
Enhanced AURORA Medical Diode System, and related accessories received FDA 510(k) clearance under submission number K230076, sponsored by Psoria-Shield, Inc.. 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 2023-03-08.
- Submission: K230076
- Applicant / Sponsor: Psoria-Shield, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2023-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.