Patient Consent Form Sofwave System

I, First Name* Last Name* understand that there are many types of treatment 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 on the use of 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 and fine lines on the skin.The procedure is non-invasive and uses an ultrasound beam.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, administer nitrous oxide, nerve blocks, oral pain medications, and/or intramuscular medications to me before the procedure to minimize the pain.Following treatment, there may be some redness and/or swelling in the treatment areas that may last for a few hours; there should be no pain when the procedure is complete, 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.

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/or-swelling, Ulceration/Erosion, Bruising.

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)

Pregnant or planning to become pregnant, having given birth less than three months ago, and/or breast feeding.
Presence of any active systemic or local infections.
Presence of active local skin disease that may alter wound healing.
History of chronic drug or alcohol abuse.
Significant scarring in the area to be treated.
Presence of a metal stent or implant in the facial area.
The Sofwave system has not been evaluated for use over various materials.
Treatment is not recommended for use directly over areas with a dermal filler.
Taking Isotretinoin or other retinoid within the past 6 months; taking psychiatric drugs, anti-platelet or anti-coagulant within the past 2 weeks.
Current or past history of melasma.

NOTE: As per the physician’s discretion, any physical or mental condition which might make it unsafe for the patient.

For additional information about the Sofwave System, I can call toll free 1-855-sofwave or log on to sofwave.com.

After learning about the Sofwave System, I choose to proceed with the Sofwave System treatment (s).

Patient Name*

Signature*

(Patient Signature)

Date*

Witnessed By:*

The patient above has signed this consent in my presence after I counseled him/her and answered his/her questions.

Print Name of Healthcare Provider*

Signature*

(Healthcare Provider Signature)

Date*

PATIENT CONSENT FORM SOFWAVE SYSTEM

Contraindications

Precautions