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FDA 510(k)

ISOLED AC-POWERED LED HEADLIGHT SYSTEM

K-Number: K102266 · 2010-09-24

ApplicantIsolux, LLC
Decision Date2010-09-24
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLED AC-POWERED LED HEADLIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isolux, LLC. It received FDA 510(k) clearance on 2010-09-24 under 510(k) number K102266. 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 ISOLED AC-POWERED LED HEADLIGHT SYSTEM?

ISOLED AC-POWERED LED HEADLIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-24. The listed applicant is Isolux, LLC. The 510(k) number is K102266.

When did ISOLED AC-POWERED LED HEADLIGHT SYSTEM receive FDA 510(k) clearance?

ISOLED AC-POWERED LED HEADLIGHT SYSTEM received FDA 510(k) clearance on 2010-09-24, under 510(k) number K102266.

Who is the listed applicant for ISOLED AC-POWERED LED HEADLIGHT SYSTEM?

The FDA 510(k) record lists Isolux, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLED AC-POWERED LED HEADLIGHT SYSTEM?

The FDA product code for ISOLED AC-POWERED LED HEADLIGHT SYSTEM 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.

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Other records listing Isolux, LLC 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.

K163185OptiLux LED IlluminatorK0529791125 XSB XENON FIBER-OPTIC 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.K113330CABLECAPSensormedK101496CABLECAP MODEL: WLF, STZ, ACMSensormedK10038821ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSMedical Illumination International, 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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