Clearance Summary
LOVELY SYSTEM received FDA 510(k) clearance under submission number K033946, sponsored by Msq (M2) , 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 2004-04-05.
- Submission: K033946
- Applicant / Sponsor: Msq (M2) , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2004-04-05
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.