CHROMOLITE SYSTEM— 510(k) K053324

Name: FDA 510(k) clearance K053324
Creator: U.S. Food and Drug Administration
Published: 2006-01-05

Substantially Equivalent

Chromogenex Plc

FDA 510(k) clearance K053324 for CHROMOLITE SYSTEM, Substantially Equivalent on 2006-01-05. Applicant: Chromogenex Plc. Device class: 2.

Clearance details

Applicant: Chromogenex Plc
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2005-12-01
Decision date: 2006-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanelli, Carmarthenshire, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.