The FDA granted premarket approval to the Allurion Gastric Balloon System for short-term weight loss in combination with a lifestyle intervention.[1] The system is drug-free and is indicated for adults aged 22 to 65 years.[1] The Allurion balloon is swallowed by patients in the form of a tablet without the need for endoscopy, anesthesia or surgery.[1][5][6] After swallowing, the balloon fills with liquid in the stomach and remains there for approximately 16 weeks, inducing a feeling of satiety.[1][8] The system is used in conjunction with a nutrition program under the supervision of a nutritionist.[1] The average weight loss is 10 to 15 kg in 16 weeks.[8][9] Contraindications include difficulty swallowing, tumors of the digestive tract or the use of anticoagulants.[1] Possible side effects include dehydration, infection, or aspiration.[1]