FDA 510(k)

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES

K-Number: K053227 · 2006-01-13

ApplicantMedical Illumination International, Inc.

Decision Date2006-01-13

Product CodeFST

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Illumination International, Inc.. It received FDA 510(k) clearance on 2006-01-13 under 510(k) number K053227. 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 LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES?

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES is a medical device that received FDA 510(k) clearance on 2006-01-13. The listed applicant is Medical Illumination International, Inc.. The 510(k) number is K053227.

When did LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES receive FDA 510(k) clearance?

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES received FDA 510(k) clearance on 2006-01-13, under 510(k) number K053227.

Who is the listed applicant for LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES?

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

What is the FDA product code for LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES?

The FDA product code for LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES is FST.

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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.