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FDA 510(k)

ALM X'TEN (X10) SURGICAL LIGHT SYSTEM

K-Number: K040735 · 2004-05-21

ApplicantAlm S.A.
Decision Date2004-05-21
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALM X'TEN (X10) SURGICAL LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alm S.A.. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K040735. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALM X'TEN (X10) SURGICAL LIGHT SYSTEM?

ALM X'TEN (X10) SURGICAL LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Alm S.A.. The 510(k) number is K040735.

When did ALM X'TEN (X10) SURGICAL LIGHT SYSTEM receive FDA 510(k) clearance?

ALM X'TEN (X10) SURGICAL LIGHT SYSTEM received FDA 510(k) clearance on 2004-05-21, under 510(k) number K040735.

Who is the listed applicant for ALM X'TEN (X10) SURGICAL LIGHT SYSTEM?

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

What is the FDA product code for ALM X'TEN (X10) SURGICAL LIGHT SYSTEM?

The FDA product code for ALM X'TEN (X10) SURGICAL LIGHT SYSTEM is FSY.

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 Alm S.A. 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.

K040015MODIFICATION TO PRISMALIX SURGICAL LIGHT

Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

Official Source

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

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