Evaluation of the Safety and Efficacy of REBORN System for Lipolysis Treatment

Exclusion Criteria

• •1. Subject underwent a prior surgical procedure(s) in the area of intended treatment within the past 6 months.
• •2. Subject underwent a prior invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
• •3. Subject underwent a prior non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
• •4. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., clexane, insulin) within the past month.
• •5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• •6. Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• •7. Subject has a history of bleeding disorder, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• •8. Subject body mass index (BMI) exceeds 30. BMI is defined as weight in kg divided by the square of the height in cm.
• •9. Subject is taking or has taken diet pills or supplements within the past month.
• •10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
• •11. Subject is pregnant or intending to become pregnant in the next 6 months.
• •12. Subject is lactating or has been lactating in the past 6 months.
• •13. Subject is unable or unwilling to comply with the study requirements.
• •14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• •15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
• •16. Subject is currently taking weight reduction medications (e.g., Saxenda).
• •17. Subject is currently taking GLP-1 receptor agonist medications (e.g., Victoza).