XENON LIGHT SOURCE PES 1— 510(k) K992540

Substantially Equivalent

Laser Optik Systeme GmbH & Co. KG

FDA 510(k) clearance K992540 for XENON LIGHT SOURCE PES 1, Substantially Equivalent on 1999-09-14. Applicant: Laser Optik Systeme GmbH & Co. KG.

Clearance details

Applicant: Laser Optik Systeme GmbH & Co. KG
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-29
Decision date: 1999-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germany, 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.