Clearance Summary
LIPSONIX(R) SYSTEM MODEL 2 received FDA 510(k) clearance under submission number K112626, sponsored by Medicis Technologies Corporation. 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 2011-10-20.
- Submission: K112626
- Applicant / Sponsor: Medicis Technologies Corporation
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4590
- Decision date: 2011-10-20
Classification & Regulation
This clearance is catalogued under FDA product code OHV and 21 CFR 878.4590, within the General, Plastic Surgery review panel as a Class II device.