Ensuring Product Authenticity & Your Safety
What is diversion?
Diversion is the selling of authentic product in channels that are not approved by or known to the manufacturer. These channels can be individuals or companies that are not authorized distributors of the manufacturer. Merz cannot ensure the authenticity or quality of Ulthera® products, including Systems, Handpieces, Transducers if these are sold through such unauthorized channels. Where this activity violates the law and/or Merz’s contractual or intellectual property rights, Merz takes action, including legal action to prevent such diversion.
What are the risks of using diverted product?
Diverted product may be expired or tampered with in such a way as to alter the product from its original form. Expired or altered/adulterated (e.g., refurbished) product that deviates from its original form may no longer be compliant with the guidelines and requirements of the applicable regulating bodies – e.g. such as the US FDA – and the product cannot be represented by the reseller or certified by Merz as safe and effective for use. Any use of such product on a patient that causes harm to the patient is done so at the risk of the provider, who may be considered responsible and liable for any legal action resulting from an adverse event or patient complaint. Merz cannot be held responsible for damages that are caused by the deviation from the original form of the diverted product, if the product is altered/adulterated or expired.
What is Merz doing to fight diversion of Ulthera® Systems and Transducers?
Merz monitors complaints and reports from around the globe to identify potentially altered and harmful product and the users of that product. Use of the Ulthera® or Ultherapy® brand names is not authorized by any user other than a direct customer of Merz or one of Merz’s authorized distributors, and unauthorized use may result in legal action. Merz supports physician practices who acquire Ulthera products from Merz or from an authorized distributor – with marketing, training, or other resources. Merz does not provide this support to any physician practice that has acquired an Ulthera® product through an unauthorized channel.
Physicians: Find the Merz office or authorized Ulthera® distributor in your country.
Patients: Find an authorized Ultherapy® provider near you via our physician locator.
How can you help us fight diversion
If you are a current Ultherapy® customer and are approached by someone, other than your Merz or known distributor representative, offering to sell you Ultherapy transducers that you fear may be altered or expired, please contact us with any information about the suspicious activity. This knowledge will help us to protect you and your investment in our proprietary technology so that you may continue to offer safe and efficacious authentic Ultherapy® treatments to your patients.
Counterfeit Product – Don’t be fooled by a fake!
Ulthera, Inc., a division of Merz, is the legal manufacturer of all authentic Ulthera® products. Counterfeit Ulthera® product is product that may look and appear to act like an Ulthera® System or Transducer, but is actually a copy manufactured by an unauthorized and thus illegitimate company. While the product may look similar, it is not manufactured in the same manner or with the same manufacturing controls and testing utilized by Merz and as required by the US FDA and other regulatory agencies. Counterfeit product presents a major risk to physician users and their patients.
The majority of counterfeit product is manufactured in China, but is exported to countries around the world where buyers are tricked by unscrupulous sellers into believing the product is authentic. To identify a fake Ulthera® System, pay close attention to any logos on the device (which may look similar but in fact are not identical to those on a genuine Ultherapy device), to the ease of use of the user interface and the model image used on the device screen, as well as to the actual imaging (in most cases this is a static image or a video loop and doesn’t actually show real tissue imaging in real-time).
If you believe you have been sold a counterfeit Ulthera® System, or if you have been approached by an individual you believe to be selling a counterfeit Ulthera® System, please contact us immediately. We can help to determine if the device is authentic or not and may be able to provide information that can help you file a claim against the seller, depending upon local law. This information also helps Merz address counterfeiting.
Contact email address: Ulthera.email@example.com
The use of trademarks or registered trademarks owned by Ulthera, Inc., including Ulthera®, Ultherapy®, DeepSEE® and SEE THE BEAUTY OF SOUND®, on counterfeit product is illegal, and manufacturers of this product are subject to legal action.
Physician customers who own the authentic Ulthera® System and have signed sales agreements with Ulthera, Merz or one of our authorized distributors, are licensed to use these trademarks to promote their use of the authentic product.