Clearance Summary
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) received FDA 510(k) clearance under submission number K230124, sponsored by Light Tree Ventures Europe B.V.. 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 2023-03-15.
- Submission: K230124
- Applicant / Sponsor: Light Tree Ventures Europe B.V.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2023-03-15
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.