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510(k) Data Aggregation

    K Number
    K250722
    Device Name
    Nd: YAG Laser Therapy System (QN-1)
    Manufacturer
    Hebei JT Medical Co., Ltd.
    Date Cleared
    2025-06-06

    (88 days)

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

    Hebei JT Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nd: YAG Laser Therapy System is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.
    Device Description
    The Nd: YAG Laser Therapy System (Model: QN-1) is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
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    K Number
    K240658
    Device Name
    1060nm laser body slimming machine
    Manufacturer
    HeBei JT Medical Co., Ltd.
    Date Cleared
    2024-05-13

    (66 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HeBei JT Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1060nm laser body slimming machine is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flank, back, and thighs.
    Device Description
    The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.
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    K Number
    K232181
    Device Name
    Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
    Manufacturer
    Hebei JT Medical Co., Ltd.
    Date Cleared
    2024-04-24

    (275 days)

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

    Hebei JT Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Body Contouring Machine can be used to: - Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - Strengthening, Toning and Firming of buttocks, thighs and calves. - Improvement of muscle tone and firmness, for strengthening muscles in arms.
    Device Description
    Body Contouring Machine is a non-invasive treatment device. The device generates an electromagnetic field that interacts with human tissue. Body Contouring Machine is equipped with four handles, two each for ZH-01 and ZH-03, which can treat different parts of the same time. The device is equipped with a 15.6-inch true-color touch screen and provides two operating modes, intelligent and professional, to meet the different needs of users. The Body Contouring Machine includes seven models in this submission, CS2,CS3,CS5,CS7, CS8,CS11, and CS13, all seven models have same principle, software, operation etc., only differences are appearance.
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