Gelesis, Inc.

Gelesis, Inc. specializes in ingested gastric satiety devices, which are designed to help manage appetite and promote satiety. These devices work by expanding in the stomach after ingestion, occupying space to reduce hunger signals. The company’s portfolio focuses on a single product category—capsules formulated to mechanically stimulate satiety.

Gelesis, Inc. is headquartered in the United States. Its devices are authorised for commercial distribution in the U.S. through the FDA’s regulatory pathways, specifically requiring premarket notification (510(k)) submissions or unique device identifier (UDI) listings, depending on the pathway used. This classification aligns with the FDA’s Class II designation for these products.

Gelesis, Inc.’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) listing system. These registries ensure transparency and compliance with U.S. regulatory requirements for medical devices.

Gelesis, Inc.’s ingested gastric satiety devices fall under the FDA’s Class II classification. This classification requires manufacturers to demonstrate that their devices are substantially equivalent to a predicate device or obtain a UDI listing, ensuring they meet specific performance and safety standards before commercial distribution.