BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS

    K Number: K100388 · Decision Jun 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    5
    Review Days
    126

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    Basic Information

    Device Name
    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
    K Number
    K100388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Illumination International, Inc.
    Date Received
    February 16, 2010
    Decision Date
    June 22, 2010
    Product Code
    FST
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FST Light, Surgical, Fiberoptic

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    Other Clearances by Medical Illumination International, Inc.

    K Number Device Name
    K140812 MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
    K053227 LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
    K010495 CENTURA PHOTOTHERAPY SPOTLIGHT
    K003489 NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8