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510(k) Data Aggregation

    K Number
    K242286
    Device Name
    Superflow Prime Treatment System (ASP-1M)
    Date Cleared
    2024-11-08

    (98 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Aimira Innovation Technology Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Superflow Prime Treatment System is used in the removal and destruction of skin lesions and coagulation of tissue.
    Device Description
    AIMIRA SFP consists of Three modules, the main body, a multi-spectral skin camera, and a plasma skin treatment handpiece. The main body includes a main cabinet, a touch screen display, a vacuum system, computer control system and power supply unit. The system runs on AiMIRA SFP software ASP-1M. The skin camera consists of multi-spectral imaging optics, and an electronic control circuit. The plasma skin treatment handpiece consists of high voltage plasma discharge circuit, high precision control electronics, a single patient use treatment probe unit, rechargeable battery system for power supply, and a wireless communication circuit to communicate with the computer in main body. A vacuum and illumination system are integrated into AIMIRA SFP to facilitate the treatment process. A multi-spectral imaging (MSI) camera is also into AIMIRA SFP system. The purpose of the MSI camera is to provide the doctor an imaging tool to record the patient's skin conditions before and after treatments as part of the patient's treatment data record.
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