Clearance Summary
Préime DermaFacial Collagen+ received FDA 510(k) clearance under submission number K243055, sponsored by EMA Aesthetics , 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 2025-04-15.
- Submission: K243055
- Applicant / Sponsor: EMA Aesthetics , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2025-04-15
Classification & Regulation
This clearance is catalogued under FDA product code PBX and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.