Clearance Summary
VIDA LED SURGICAL LIGHTING SYSTEM received FDA 510(k) clearance under submission number K132307, sponsored by Convida Healthcare & Systems Corporation. 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 2013-11-05.
- Submission: K132307
- Applicant / Sponsor: Convida Healthcare & Systems Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2013-11-05
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.