ALPHAXENON LIGHT 180 W AND 300 W— 510(k) K093125

Substantially Equivalent

Gimmi GmbH

FDA 510(k) clearance K093125 for ALPHAXENON LIGHT 180 W AND 300 W, Substantially Equivalent on 2010-01-27. Applicant: Gimmi GmbH.

Clearance details

Applicant: Gimmi GmbH
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-02
Decision date: 2010-01-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tuttlingen, DE

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Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

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.