ZF 720— 510(k) K132551

Name: FDA 510(k) clearance K132551
Creator: U.S. Food and Drug Administration
Published: 2014-06-30

Substantially Equivalent

Umbel Corporation

FDA 510(k) clearance K132551 for ZF 720, Substantially Equivalent on 2014-06-30. Applicant: Umbel Corporation. Device class: 2.

Clearance details

Applicant: Umbel Corporation
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2013-08-14
Decision date: 2014-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

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K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09
K140460 — MACH LED 2SC2014-04-03

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.