| Eligibility |
Inclusion Criteria:
1. Age 18~55 years;
2. Abdominal fat thickness of at least 2.0 cm;
3. Body mass index (BMI) <28.0 kg/m2;
4. Simple localized obesity with abdominal subcutaneous fat accumulation;
5. Those who voluntarily participate in this clinical trial and sign informed consent,
agreeing to maintain the same dietary and exercise habits during the study period as
before treatment, and to maintain changes in body weight of no more than ±6%;
6. For women of childbearing potential with negative serum pregnancy tests at
Screening/baseline;
7. Those who have not participated in any clinical trials within three months prior to
enrollment.
Exclusion Criteria:
1. Pregnant women, breastfeeding women or women at childbearing age who are expected to
become pregnant or who are prone to contraceptive failure;
2. Subjects with pacemakers, implantable cardiac defibrillators or other electromagnetic
implantable medical systems;
3. History of underlying medical conditions such as hypertension (blood pressure = 140/90
mmHg), hyperlipidemia, diabetes, hyperthyroidism or hypothyroidism;
4. Patients who are positive for 4 preoperative infection tests (including anti-human
immunodeficiency virus antibodies, syphilis spirochete-specific antibodies, hepatitis
C virus antibodies, and hepatitis B surface antigen, in which any one of these is
positive);
5. Patients with autoimmune or connective tissue diseases or malignant tumors;
6. Those with cardiac, hepatic or renal insufficiency (Alanine aminotransferase or
Aspartate Transaminase > 1.5 times the upper limit of normal; Blood urea nitrogen >
1.5 times the upper limit of normal or Cr > the upper limit of normal; ischemic heart
disease; cardiac valvular disease; congestive heart failure);
7. Abnormal coagulation, abnormal blood counts, and dyslipidemia (total cholesterol,
triglycerides, or LDL exceeding 20% of the upper limit of the normal range);
8. History of exposure to high fat-soluble compounds (e.g., pesticides, herbicides, or
drugs known to be stored in fat, except oral contraceptives), use of retinoids within
the last 1 month;
9. History of lacerations or dermatologic conditions, active dermatologic conditions,
known tendency to form keloids or poor wound healing in the area of treatment; current
infectious lesions in the area of treatment and its immediate vicinity;
10. Abdominal hernia, diastasis recti or known abdominal aortic aneurysm (abdominal
treatment);
11. History of fat reduction procedures at the treatment site (e.g., undergoing
liposuction, surgery, use of lipolytic agents, etc.) or history of other surgeries or
presence of implants at the required treatment site and its adjacent areas;
12. Non-invasive or minimally invasive fat reduction, skin tightening, or lipolysis
treatments such as ultrasound, radiofrequency, etc., on the abdomen within the past 6
months;
13. Received weight loss treatment methods (including medication, physical therapy and
controlled diet and exercise therapy) within the past 1 month;
14. Those who are allergic to medical device treatments and excipients and acoustic gel
for this treatments;
15. Concomitant use with anti-aggregating drugs (non-steroidal anti-inflammatory drugs
NSAIDS, etc.). o) Concomitant use with anticoagulant drugs (Warfarin, etc.);
16. Subjects with unrealistic expectations of therapeutic efficacy;
17. Patients with legally defined disabilities (blindness, deafness, dumbness, mental
retardation, physical disability);
18. Persons with mental disorders;
19. Patients who are unable or unwilling to comply with the requirements of the study;
20. Subject is in other conditions deemed unsuitable for the trial by the investigator
judgment.
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