Clearance Summary
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V received FDA 510(k) clearance under submission number K100230, sponsored by Eleme Medical, Inc.. 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 2010-04-02.
- Submission: K100230
- Applicant / Sponsor: Eleme Medical, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2010-04-02
Classification & Regulation
This clearance is catalogued under FDA product code NUV and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.