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Epitomee is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m², when used in conjunction with diet and exercise.

The subject device of this 510(k) notification, Epitomee, is comprised of two components: The outer component is a capsule and the inner component contains superabsorbent hydrogel particles. Each particle is approximately 250 microns in size. The particles are enclosed in pH sensitive compartments. Once Epitomee is swallowed, the capsule disintegrates in the stomach and releases the pH sensitive compartments. By absorption of water in the stomach fluid, the superabsorbent particles within the compartments swell to form a three-dimensional matrix designed to occupy volume in the stomach that creates a sensation of fullness, enabling weight loss. Epitomee mechanism of action is purely mechanical and does not involve any chemical activity. Epitomee works directly in the gastrointestinal (GI) tract. Epitomee is provided non-sterile.