LUCEA LED SURGICAL LIGHT SYSTEM— 510(k) K113679

Substantially Equivalent

Maquet S.A.S.

FDA 510(k) clearance K113679 for LUCEA LED SURGICAL LIGHT SYSTEM, Substantially Equivalent on 2012-01-12. Applicant: Maquet S.A.S..

Clearance details

Applicant: Maquet S.A.S.
Product code: Code NTN
Advisory panel: Gastroenterology, Urology
Date received: 2011-12-14
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Wayne, NJ, US

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Adverse events under product code NTN

product code NTN

Other: 1
Total: 1

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.