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510(k) Data Aggregation

    K Number
    K250198
    Device Name
    Laon Ortho
    Manufacturer
    LAON MEDI Inc.
    Date Cleared
    2025-04-23

    (90 days)

    Product Code
    PNN, LLZ
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAON MEDI Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laon Ortho is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Laon Ortho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
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    K Number
    K232564
    Device Name
    Align Studio
    Manufacturer
    Laon Medi Inc.
    Date Cleared
    2024-03-12

    (201 days)

    Product Code
    PNN, LLZ
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laon Medi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. The use of the Align Studio requres the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
    Device Description
    Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
    Ask a Question

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