VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES— 510(k) K140930

Name: FDA 510(k) clearance K140930
Creator: U.S. Food and Drug Administration
Published: 2014-06-09

Substantially Equivalent

Convida Healthcare & Systems Corporation

FDA 510(k) clearance K140930 for VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES, Substantially Equivalent on 2014-06-09. Applicant: Convida Healthcare & Systems Corporation. Device class: 2.

Clearance details

Applicant: Convida Healthcare & Systems Corporation
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2014-04-11
Decision date: 2014-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan County, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

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K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140460 — MACH LED 2SC2014-04-03

More clearances from Convida Healthcare & Systems Corporation

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K132307 — VIDA LED SURGICAL LIGHTING SYSTEM2013-11-05

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.