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510(k) Data Aggregation

    K Number
    K232982
    Device Name
    EMS Sculpt Machine
    Manufacturer
    Shandong Huamei Technology Co.,Ltd.
    Date Cleared
    2024-11-25

    (430 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huamei Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMS Sculpt Machine is indicated to be used for: - · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - · Strengthening, Toning and Firming of buttocks and thighs.
    Device Description
    The EMS Sculpt Machine is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the EMS Sculpt Machine helps to strengthen and firm the abdomen, buttocks and thighs. The EMS Sculpt Machine is equipped with a LCD touch screen that significantly facilitates the use of the device. The user exchanges with the system by the LCD and the keys on it. The state of the system, the operation interface, the instructions and hints to the user will be shown on the LCD.
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    K Number
    K162659
    Device Name
    Diode Laser Hair Removal System
    Manufacturer
    SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
    Date Cleared
    2017-06-16

    (263 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG HUAMEI TECHNOLOGY CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); Function module description a. Control Panel The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator. b. Main Control Module The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working. c. Constant current board module The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module. d. Temperature and humidity control system The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working. e. Handpiece module Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.
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