Clearance Summary
Project E Beauty LED Light Therapy Mask (Model: PE730) received FDA 510(k) clearance under submission number K214101, sponsored by Duplex International Trading Limited. 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 2022-03-23.
- Submission: K214101
- Applicant / Sponsor: Duplex International Trading Limited
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-03-23
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.