I hereby authorize Dr. Kaga or staff under Dr. Kaga's supervision to treat me with the SOFWAVE device.

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 scars and upper arms 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

I understand that SOFWAVE works by using radio frequency (RF) energy to provide uniform tissue heating for the purpose of elevating tissue temperature for the treatment of selective medical conditions. There is little or no downtime associated with this treatment. It is possible the result will be minimal or not help at all. I am aware that office policy is that there are no refunds or credit given for dissatisfaction or undesirable results. I understand that the device being used for skin appearance improvement, of which | am consenting. | understand that clinical results may vary depending on individual factors, including but not limited to medical history, skin type, patient compliance with pre- and post-treatment instructions, and individual response to treatment. I understand that there is a possibility of short-term effects such as reddening, mild burning, temporary bruising and temporary discoloration of the skin, as well as the possibility of rare side effects such as scarring and permanent discoloration. These effects have been fully explained to me. I understand that treatment with this system involves a series of treatments and the fee structure has been fully explained to me I certify that I have been fully informed of the nature and purpose of the procedure, expected outcomes and possible complications, and I understand that no guarantee can be given as to the final result obtained. I am fully aware that my condition is of cosmetic concern and that the decision to proceed is based solely on my expressed desire to do so. I confirm that | have informed the staff regarding any current or past medical condition, disease or medication taken. The procedure may result in the following adverse experiences or risks:

• DISCOMFORT/PAIN: Moderate discomfort during treatment is expected. Mild discomfort or slight tenderness in the treatment area may persist for a few hours following treatment, potentially extending to a few days.
• REDNESS/SWELLING/BRUISING: Short term redness (hyperemia) is expected following treatment and typically persists for several hours. In addition, swelling (edema) and/or bruising of the treated area may occur and typically resolve within 24 hours to a few days.
• BRUISING/PETECHIAE OUTSIDE THE TREATMENT AREA: May occur under the area where the decal is applied and can occur in the process of removing the decal from patient's skin.
• LUMPS: Firm edemic areas may develop in the treated area 24 to 72 hours following treatment, and typically resolve without intervention over several weeks. If lumps do develop, they are typically tender to touch.
• WOUNDS: Treatment can result in burning, blistering, crusting, scabbing or bleeding of the treated areas. If any of these occur, please call our office 732-719-2001.
• INFECTION: Infection is a possibility whenever the skin surface is disrupted, although proper wound care should prevent this. If signs of infection develop, such as pain, heat, or surrounding redness, please call our office 732-719-2001.
• It is IMPORTANT that you follow all post-treatment instructions provided by your healthcare staff.
• SCARRING: Scarring is a rare occurrence, but it is a possibility if the skin surface is disrupted. To minimize the chances of scarring, it is IMPORTANT that you follow all post-treatment instructions provided by your healthcare staff.
• SKIN COLOR CHANGES: If the skin surface is disrupted, there is a possibility that the area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent.
• NUMBNESS: Temporary numbness may occur, but is rare.
• I acknowledge the following points have been discussed with me:
• Potential benefits of the proposed procedure, including the possibility that the procedure may not work for me
• Alternative treatments such as surgery
• Reasonably anticipated health consequences if the procedure is not performed.
• Possible complications/risks involved with the proposed procedure and subsequent healing perio For women of childbearing age:
• By signing below I confirm that I am not pregnant and do not intend to become pregnant anytime during the course of treatment.
• Furthermore, I agree to keep Dr. Kaga and staff informed should I become pregnant during the course of treatment.

I understand that the following conditions are contraindications and that I do not have any of the following:

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

I understand that the following conditions are precautions and that I understand the risk involved. 

• 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.

• History of melasma.

• History of recent local skin infection in the intended treatment area (such as HSV-1,Varicella Zoster, dermatitis, acne, etc.).

Sofwave No-fly Zones
I understand that certain areas of the body are considered “no-treatment” zones for safety reasons during Sofwave procedures. These include, but are not limited to:

- The thyroid area (front of the neck)

- Eyelids and areas directly over the eyes

- Areas with active infections, open wounds, or inflammation

- Areas with metal implants, dermal fillers, or tattoos (as advised)

- Any area where nerves are close to the surface (e.g., jawline, temples)

I acknowledge that treating these areas can increase the risk of side effects such as skin irritation, nerve sensitivity, or unwanted tissue reactions.

By signing this form, I confirm that:

- I have disclosed any relevant medical conditions or implants

- I will follow pre- and post-treatment care instructions

- I consent to treatment 

 I understand the risks to treatment in the zones listed above. 

BY MY SIGNATURE BELOW, I ACKNOWLEDGE THAT | HAVE READ AND FULLY UNDERSTAND THE CONTENTS OF THIS INFORMED CONSENT, AND THAT I HAVE HAD ALL MY QUESTIONS ANSWERED TO MY SATISFACTION BY MY HEALTHCARE TEAM.