Clearance Summary
VIVACE Electrosurgical System received FDA 510(k) clearance under submission number K150409, sponsored by Sung Hwan E&B Co.,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 2016-01-15.
- Submission: K150409
- Applicant / Sponsor: Sung Hwan E&B Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2016-01-15
Classification & Regulation
This clearance is catalogued under FDA product code OUH and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.