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FDA 510(k)

LUMINEX LL LASER SYSTEM

K-Number: K063574 · 2007-01-29

ApplicantMedical Laser Systems, Inc.
Decision Date2007-01-29
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMINEX LL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 2007-01-29 under 510(k) number K063574. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMINEX LL LASER SYSTEM?

LUMINEX LL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-29. The listed applicant is Medical Laser Systems, Inc.. The 510(k) number is K063574.

When did LUMINEX LL LASER SYSTEM receive FDA 510(k) clearance?

LUMINEX LL LASER SYSTEM received FDA 510(k) clearance on 2007-01-29, under 510(k) number K063574.

Who is the listed applicant for LUMINEX LL LASER SYSTEM?

The FDA 510(k) record lists Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMINEX LL LASER SYSTEM?

The FDA product code for LUMINEX LL LASER SYSTEM is NHN.

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 Medical Laser Systems, Inc. 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.

K082969LUMINEX INFRARED LAMP SYSTEM

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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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