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FDA 510(k)

CENTURA PHOTOTHERAPY SPOTLIGHT

K-Number: K010495 · 2001-03-09

ApplicantMedical Illumination International, Inc.
Decision Date2001-03-09
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTURA PHOTOTHERAPY SPOTLIGHT 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 2001-03-09 under 510(k) number K010495. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTURA PHOTOTHERAPY SPOTLIGHT?

CENTURA PHOTOTHERAPY SPOTLIGHT is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Medical Illumination International, Inc.. The 510(k) number is K010495.

When did CENTURA PHOTOTHERAPY SPOTLIGHT receive FDA 510(k) clearance?

CENTURA PHOTOTHERAPY SPOTLIGHT received FDA 510(k) clearance on 2001-03-09, under 510(k) number K010495.

Who is the listed applicant for CENTURA PHOTOTHERAPY SPOTLIGHT?

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 CENTURA PHOTOTHERAPY SPOTLIGHT?

The FDA product code for CENTURA PHOTOTHERAPY SPOTLIGHT is LBI.

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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.

K10038821ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSK053227LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPESK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8

Related Devices (Code: LBI)

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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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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