Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM

K-Number: K971057 · 1997-03-28

ApplicantCogent Light Technologies, Inc.
Decision Date1997-03-28
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Light Technologies, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K971057. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM?

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Cogent Light Technologies, Inc.. The 510(k) number is K971057.

When did COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM receive FDA 510(k) clearance?

COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM received FDA 510(k) clearance on 1997-03-28, under 510(k) number K971057.

Who is the listed applicant for COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM?

The FDA 510(k) record lists Cogent Light Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM?

The FDA product code for COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM is GCT.

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 Cogent Light Technologies, 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.

K001698MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159K983714SOLARTEC SOURCE 270, MODEL # 90123K936048LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)K933405COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE

Related Devices (Code: GCT)

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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.

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.

↑