Quality and Risk
Allurion Technologies is committed to designing and manufacturing medical products of the highest quality. Allurion received ISO13485:2016 certification of the quality management system that governs the production and manufacturing of the Allurion System.
This medical device is a regulated healthcare product, which under European regulations bears the CE mark.
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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 surgical intervention for removal.
To further clarify risks and benefits of the Allurion device, please discuss with your physician.