FDA.reportPublic FDA data

GELESIS SRL

Matched from indexed company URL: GELESIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121211873012121187GELESIS SRL1N2026-01-01Via Europa, 187 Calimera Lecce IT 73021
30121217943012121794GELESIS INC1Y2020-04-25501 Boylston St Suite 6102 Boston MA US 02116

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860517002603Plenity™ - Super-absorbent hydrogel to aid in weight management.1-844-753-6489info@gelesis.com
00860517002634Plenity™ - Super-absorbent hydrogel to aid in weight management.1-844-753-6489info@gelesis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2306031720029584K230133PlenityQFQ2024-01-19
2306261527730835DEN180060PlenityQFQ2019-04-12
2306031796203417DEN180060PlenityQFQ2019-04-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QFQ32024-01-19

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.

GELESIS SRL

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.

GELESIS SRL

2026-01-14