Clearance Summary
Psoria-Shield AURORA received FDA 510(k) clearance under submission number K192411, sponsored by Psoria-Shield. 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 2020-07-02.
- Submission: K192411
- Applicant / Sponsor: Psoria-Shield
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2020-07-02
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.