Clearance Summary
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) received FDA 510(k) clearance under submission number K241718, sponsored by Shenzhen Aozemei Technology 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 2024-10-28.
- Submission: K241718
- Applicant / Sponsor: Shenzhen Aozemei Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-10-28
Classification & Regulation
This clearance is catalogued under FDA product code OHS and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.