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FDA 510(k)

LUCEA LED SURGICAL LIGHT SYSTEM

K-Number: K113679 · 2012-01-12

ApplicantMaquet S.A.S.
Decision Date2012-01-12
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUCEA LED SURGICAL LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Maquet S.A.S.. It received FDA 510(k) clearance on 2012-01-12 under 510(k) number K113679. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCEA LED SURGICAL LIGHT SYSTEM?

LUCEA LED SURGICAL LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-12. The listed applicant is Maquet S.A.S.. The 510(k) number is K113679.

When did LUCEA LED SURGICAL LIGHT SYSTEM receive FDA 510(k) clearance?

LUCEA LED SURGICAL LIGHT SYSTEM received FDA 510(k) clearance on 2012-01-12, under 510(k) number K113679.

Who is the listed applicant for LUCEA LED SURGICAL LIGHT SYSTEM?

The FDA 510(k) record lists Maquet S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUCEA LED SURGICAL LIGHT SYSTEM?

The FDA product code for LUCEA LED SURGICAL LIGHT SYSTEM is NTN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Maquet S.A.S. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130513VOLISTA 400; VOLISTA 600

Related Devices (Code: NTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbHK122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.K103813SOPRO 281SoproK102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.K090601FSC 2Schoelly Imaging, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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