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FDA 510(k)

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS

K-Number: K100388 · 2010-06-22

ApplicantMedical Illumination International, Inc.
Decision Date2010-06-22
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS 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 2010-06-22 under 510(k) number K100388. 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 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS?

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-06-22. The listed applicant is Medical Illumination International, Inc.. The 510(k) number is K100388.

When did 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS receive FDA 510(k) clearance?

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS received FDA 510(k) clearance on 2010-06-22, under 510(k) number K100388.

Who is the listed applicant for 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS?

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 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS?

The FDA product code for 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS is FST.

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Other records listing Medical Illumination International, 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.

K053227LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPESK010495CENTURA PHOTOTHERAPY SPOTLIGHTK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8

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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