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

    UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL

    K Number: K134009 · Decision Oct 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    289

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    Basic Information

    Device Name
    UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
    K Number
    K134009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtek Lighting
    Date Received
    December 30, 2013
    Decision Date
    October 15, 2014
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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