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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.

Plenity® is indicated to aid in weight management in adults with excess weight or obesity, with a Body Mass Index (BMI) of 25 to 40 kg/m2, when used in conjunction with diet and exercise.

Plenity is a porcine gelatin capsule that contains thousands of absorbent hydrogel particles (0.75 grams [g] per capsule); each particle is approximately the size of a grain of salt. Plenity OTC is non-systemic and works directly in the gastrointestinal (GI) tract. Plenity OTC hydrogel is made from two naturally derived ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. Plenity OTC is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity OTC particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity OTC particles from the 2.25 g/dose occupy about a quarter of the average stomach volume. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine. Plenity OTC passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements; they are not absorbed by the body. Patients consume three (3) capsules (2.25 g/dose) with water before both lunch and dinner. Plenity OTC is supplied in peelable pods that provide the two doses patients take daily. Each individual pod holds a single dose of three (3) capsules. Plenity OTC pods are supplied in a monthly kit.

Plenity 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.

Plenity is a porcine gelatin capsule that contains thousands of absorbent hydrogel particles (0.75 grams [g] per capsule); each particle is approximately the size of a grain of salt. Plenity is non-systemic and works directly in the gastrointestinal (GI) tract. Plenity hydrogel is made from two natural ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. Plenity is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity particles from the 2.25 g/dose occupy about a quarter of the average stomach volume. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements; they are not absorbed by the body. Patients consume three (3) capsules (2.25 g/dose) with water before both lunch and dinner. Plenity is supplied in double blister packs that, together, provide the two doses patients take daily. Each individual blister pack holds a single dose of three (3) capsules. Seven (7) double blister packs are supplied in a weekly package.