Clearance Summary
Aimanfun Lumea Comfort, A-2789/A-3588 received FDA 510(k) clearance under submission number K212907, sponsored by Kam Yuen Plastic Products , Ltd.. 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 2021-12-02.
- Submission: K212907
- Applicant / Sponsor: Kam Yuen Plastic Products , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2021-12-02
Classification & Regulation
This clearance is catalogued under FDA product code ONF and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.