DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD— 510(k) K042382

Name: FDA 510(k) clearance K042382
Creator: U.S. Food and Drug Administration
Published: 2004-11-30

Substantially Equivalent

Med-General Technologies, LLC

FDA 510(k) clearance K042382 for DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD, Substantially Equivalent on 2004-11-30. Applicant: Med-General Technologies, LLC. Device class: 2.

Clearance details

Applicant: Med-General Technologies, LLC
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2004-09-01
Decision date: 2004-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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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.