Cleared Traditional

VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES

K140930 · Convida Healthcare & Systems Corporation · General & Plastic Surgery
Jun 2014
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K140930 is an FDA 510(k) clearance for the VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES, a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY), submitted by Convida Healthcare & Systems Corporation (Taoyuan County, TW). The FDA issued a Cleared decision on June 9, 2014, 59 days after receiving the submission on April 11, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K140930 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2014
Decision Date June 09, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FSY — Light, Surgical, Ceiling Mounted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580