Treatment Description:

Sofwave is a non-invasive skin treatment utilizing high-frequency ultrasound technology to stimulate collagen production and improve skin appearance. It is commonly used for skin tightening and wrinkle reduction.

I understand that there are many types of treatments for fine lines and wrinkles and that each has its own benefits, risks, and potential side effects. The treatment with the Sofwave System requires a non-invasive, dermatological procedure performed by a healthcare provider who is trained to use this product.

By completing this patient consent form, I am consenting to the treatment with the Sofwave System and acknowledging that I have read and understood the following points and all information contained in this form and made an informed and careful decision to receive the treatment with the Sofwave System.

• The Sofwave System is used to treat wrinkles, fine lines, cellulite , acne scars1 and upper arms1 appearance on the skin.
• The procedure is non-invasive and uses ultrasound beams.
• The Sofwave system delivers ultrasound energy to the skin. The heat from the ultrasound stimulates new collagen and elastin to form.
• I understand that there may be some discomfort during the treatment when the ultrasound beam is being delivered.
• My healthcare provider may choose to apply a topical anesthetic and/or administer nitrous oxide and/or nerve blocks and/or intramuscular Toradol to me before the procedure to minimize the pain.
• Following treatment, there may be some redness and/or swelling on the treated area that may last for few hours; there should be no pain when the procedure is completed while post-procedure discomfort or tenderness is possible.
• My experience in receiving the treatment and the results of my treatment may be different from others.
• The Treatment may be done using the Lift or Precise handpieces (applicators). The Lift applicator contains 7 Ultrasound transducers, and the Precise applicator contains 3 Ultrasound transducers. The transducers in both applicators are identical. The healthcare provider will decide which one to use according to the treatment areas (can use one or both of the applicators).
• While receiving treatment with the Sofwave System can provide potential benefits for me, there are also potential risks/complications associated with the treatment. These risks include, but may not be limited to, the following:
  • Burn
  • Significant pain
  • Tenderness
  • Changes in skin pigmentation
  • Persistent redness and/or swelling
  • Ulceration/Erosion
  • Bruising

Contraindications

• Pacemakers and electronic device implants in treatment area(s)
• Open wounds or lesions on the treatment area(s)
• Severe or cystic acne on the treatment area(s)

Off-Label Use Notice

Certain treatments provided during your session may involve the use of products or procedures in areas that are considered “off-label.” This means that while the treatment may not be specifically approved by regulatory bodies for the exact area being treated, it has been used in this manner based on clinical experience and evidence supporting its safety and efficacy

Understanding Off-Label Use:

• Definition: Off-label use refers to the application of a treatment or product in a manner not specifically approved by regulatory agencies, such as the FDA. This can include using products in areas or for conditions not explicitly listed in the product’s official guidelines.
• Risks and Benefits: While off-label use can be effective and is often supported by clinical evidence and professional experience, it may carry risks or uncertainties not fully detailed in standard usage guidelines. We will provide you with information on the potential benefits and risks of the treatment and address any questions you may have.
• Informed Consent: By signing this consent form, you acknowledge that you have been informed about the off-label nature of certain treatments and agree to proceed with the understanding that these uses are based on professional judgment and experience.

If you have any concerns or questions about the treatments or their off-label use, please do not hesitate to discuss them with us before proceeding.

The nature and purpose of this elective procedure and the complications and side effects have been fully explained to me. Alternative treatments and their risks and benefits have been explained to me and I understand that I have a right to refuse treatment. I agree to adhere to all safety precautions and instructions after the treatment. I have been instructed in and understand post treatment instructions and have been offered a written copy of them. I understand that no refunds will be given for treatments received. No guarantee has been given by anyone as to the results that may be obtained by this treatment.

I have read this informed consent and certify that I understand its contents in full. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. I have had enough time to consider the information given me and feel that I am sufficiently advised to consent to this procedure. I accept the risks and complications of the procedure. I certify if any changes occur in my medical history I will notify the office.

I hereby give my voluntary consent to this elective procedure and release the facility, medical staff, and specific technicians from liability associated with the procedure. I certify that I am a competent adult of at least 18 years of age and am not under the influence of alcohol or drugs. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors and assigns.

I agree, if I should have any questions or concerns regarding my treatment / results I will notify this office at immediately so that timely follow-up and intervention can be provided.