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FDA 510(k)

LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)

K-Number: K936048 · 1994-03-10

ApplicantCogent Light Technologies, Inc.
Decision Date1994-03-10
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) 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 1994-03-10 under 510(k) number K936048. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)?

LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Cogent Light Technologies, Inc.. The 510(k) number is K936048.

When did LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) receive FDA 510(k) clearance?

LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) received FDA 510(k) clearance on 1994-03-10, under 510(k) number K936048.

Who is the listed applicant for LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)?

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 LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)?

The FDA product code for LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) is FST.

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 # 90123K971057COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEMK933405COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE

Related Devices (Code: FST)

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.

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker SpineK113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.K113330CABLECAPSensormedK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLCK101496CABLECAP MODEL: WLF, STZ, ACMSensormed

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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