BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    Klox Biophotonic LumiHeal System

    K Number: DEN200005 · Decision Dec 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    668

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    Basic Information

    Device Name
    Klox Biophotonic LumiHeal System
    K Number
    DEN200005
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4880
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Klox Technlogies, Inc.
    Date Received
    February 4, 2020
    Decision Date
    December 3, 2021
    Product Code
    QPE
    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
    QPE Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions