This medical device is a regulated healthcare product, which under European regulations bears the CE mark. The Allurion Balloon is a temporary weight loss aid for adults over the age of 18 who are overweight or obese, defined as a body mass index (BMI) ≥ 27. The Allurion Balloon can only be administered by a healthcare professional who is knowledgeable about the use of the Allurion Balloon. The Allurion Balloon must be used in conjunction with a supervised nutrition and behavior modification program. Some individuals may not be eligible to receive the Allurion Balloon. Your doctor will take a detailed medical history and perform a physical examination to determine your eligibility. It is important to provide your physician with a complete and accurate medical history. In rare cases, the Allurion Balloon may require endoscopic or other surgical intervention for removal. This is not a complete listing of potential complications; for Important Safety Information, go to www.allurion.com/en/risk-information/.
This material is not intended for a U.S. audience. This material describes our product, which has not been approved or cleared for marketing by the U.S. Food and Drug Administration and is an investigational device. Our product is not available for sale in the United States.
Allurion is a registered trademark in the US of Allurion Technologies and Allurion is a registered trademark of Allurion Technologies in the US and the EU.
