Clearance Summary
Lancet received FDA 510(k) clearance under submission number K221839, sponsored by Hebei Xinle Sci&Tech Co., Ltd.. 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 2022-09-19.
- Submission: K221839
- Applicant / Sponsor: Hebei Xinle Sci&Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2022-09-19
Classification & Regulation
This clearance is catalogued under FDA product code FMK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.