Saying it’s the Same Doesn’t Make It So
Protect Your Patients and Your Practice
Beware of Risks Counterfeits Bring to Your Practice
Counterfeit products carry substantial risks to you and your practice1:- Lack of clinical efficacy
- Patient injury or unanticipated adverse events
- Patient dissatisfaction
- Loss of medical license/malpractice
- Legal liability: civil or criminal prosecution
- 100+ patents
- 10+ years of R&D
- 50+ clinical trials
- 4 U.S. FDA indications
- 60+ published, peer-reviewed papers
- CE mark in Europe
The Ultherapy® Difference
The below example highlights the difference between energy delivered via an authentic Ulthera® System versus a counterfeit device.Ulthera® System
Precise, targeted delivery of TCPs all at the same depth
A Counterfeit System
Uncontrolled delivery of heat energy all in the same location
- Instead of delivering a whole line of thermal coagulation points (TCPs), the counterfeit device created only a single TCP, meaning a full treatment is never delivered. How it works
- The single TCP from the counterfeit device is too large and potentially too close to the surface, which can result in burns. The Ulthera® System limits the energy output for safety reasons.
Buyers Beware of Copycats’ False Claims
Many so-called medical devices claim to work the same way Ultherapy does–but there is only one authentic Ultherapy treatment. With the rigorous pre-clinical and clinical research done utilizing the true UIthera® System, others can’t come close to providing the same level of safety and treatment data to support their claims. When assessing any new technology for your practice, it’s important to ensure the device is approved for use in your country. It can also be comforting to know that organizations such as the U.S. FDA–which have stringent safety and efficacy requirements–have also cleared the device for use. Legal implications for using non-approved medical devices will vary by country, so make sure you are familiar with your local laws and regulations to ensure the safety of your practice| Ultherapy | Competitors | |
|---|---|---|
| US FDA-cleared | Yes | ? |
| CE Mark | Yes | ? |
| System warranty and technical support | Yes | ? |
| Hands-on clinical training | Yes | ? |
| Practice marketing support | Yes | ? |
| Backed by Merz Aesthetics | Yes | ? |
Authorized Purchase Channels
When you’re ready to put Ultherapy into action in your practice, make sure that you obtain a true Ulthera® System only from Merz directly or from one of our Authorized Distributors. Purchasing a device from channels such as Alibaba.com or Ebay.com could mean that you are getting a counterfeit device. Or, it could be an actual Ulthera® System that has not been properly maintained and may not function as intended. If a product is purchased from outside our authorized distributors, Merz is unable to provide ongoing support and training.
If you acquire an authentic Ulthera® System from Merz or an authorized distributor, you will receive a Certificate of Authenticity you can show patients to prove your commitment to providing them with an authentic Ultherapy treatment. When you become an authorized provider with us, you will have access to ongoing company support to keep you apprised of our ever-evolving science, such as new indications, updates to our platform technology and improvements to our software.
- Biesman B and Patel N. Physician alert: beware of counterfeit medical devices. Lasers Surg Med. 2014;46(7):528-30.