Clearance Summary
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 received FDA 510(k) clearance under submission number K220549, sponsored by Hans Biomed Corporation. 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 2023-03-07.
- Submission: K220549
- Applicant / Sponsor: Hans Biomed Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4840
- Decision date: 2023-03-07
Classification & Regulation
This clearance is catalogued under FDA product code NEW and 21 CFR 878.4840, within the General, Plastic Surgery review panel as a Class II device.