Clearance Summary
Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 received FDA 510(k) clearance under submission number K231005, sponsored by Supermax Healthcare Canada-Supermax Medical. 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 2023-12-05.
- Submission: K231005
- Applicant / Sponsor: Supermax Healthcare Canada-Supermax Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2023-12-05
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.