# K230133: Plenity

- Pathway: 510(k) (Traditional)
- Applicant: Gelesis, Inc.
- Decided: Jan 19, 2024 after 367 days
- Product code: QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss)
- Device class: 2
- Regulation: 21 CFR 876.5982
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180060 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180060: Plenity, Gelesis, Inc. (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K230133
Methodology: https://510kreport.com/methodology