gelesis.comPlenity
Gelesis, Inc.
GELESIS SRL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012121187 | 3012121187 | GELESIS SRL | 1 | N | 2026-01-01 | Via Europa, 187 Calimera Lecce IT 73021 |
| 3012121794 | 3012121794 | GELESIS INC | 1 | Y | 2020-04-25 | 501 Boylston St Suite 6102 Boston MA US 02116 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860517002603 | Plenity™ - Super-absorbent hydrogel to aid in weight management. | 1-844-753-6489 | info@gelesis.com |
| 00860517002634 | Plenity™ - Super-absorbent hydrogel to aid in weight management. | 1-844-753-6489 | info@gelesis.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 230603 | 1720029584 | K230133 | Plenity | QFQ | 2024-01-19 |
| 230626 | 1527730835 | DEN180060 | Plenity | QFQ | 2019-04-12 |
| 230603 | 1796203417 | DEN180060 | Plenity | QFQ | 2019-04-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QFQ | 3 | 2024-01-19 |
PMN#
GUDID#
Plenity® - Plenity is a porcine gelatin capsule that contains a hydrogel powder (0.75 grams per capsule). Plenity is non-systemic and works directly in the gastrointestinal tract. Plenity 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 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 a dose of three (3) capsules supplied in a single peelable pod. Patients take daily two doses with water, before both lunch and dinner. Plenity pods are supplied in a monthly kit for 28 days (4 weeks) of treatment.
2026-01-14
Plenity® - Plenity is a porcine gelatin capsule that contains a hydrogel powder (0.75 grams per capsule). Plenity is non-systemic and works directly in the gastrointestinal tract. Plenity 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 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 a dose of three (3) capsules supplied in a single peelable pod. Patients take daily two doses with water, before both lunch and dinner. Plenity pods are supplied in a monthly kit for 28 days (4 weeks) of treatment.
2026-01-14
Plenity™ - Super-absorbent hydrogel to aid in weight management.
2020-05-06
Plenity® - Super-absorbent hydrogel to aid in weight management.CHN
2020-12-09
Plenity™ - Super-absorbent hydrogel to aid in weight management.
2020-03-09
Plenity® - Super-absorbent hydrogel to aid in weight management. Welcome Kit.
2021-09-01
Plenity® - Super-absorbent hydrogel to aid in weight management. Refill Kit.
2021-09-01
Plenity™ - Super-absorbent hydrogel to aid in weight management.
2020-05-06
Plenity™ - Super-absorbent hydrogel to aid in weight management.
2020-03-09