Allurion Technologies, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011299930	3011299930	Allurion Technologies, Inc.	1	N	2026-01-01	11 Huron Dr Natick MA US 01760

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
176845	1304306641	P250023	Allurion™ Gastric Balloon System	LTI	2026-02-20
176845	1402516011

GUDID#

Allurion™ Gastric Balloon System - Approval for the Allurion Gastric Balloon System (AGBS) is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) greater than or equal to 30 kg/m2 and less than or equal to 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program. The residence time for each AGBS is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a 10-month period.
Allurion Technologies, Inc.
2026-04-07
Allurion™ Filler Kit - The Allurion Filler Kit is comprised of the following items:• Filler Bag containing sterilized Filling Fluid and a Septum Port to connect to the Extension Hose.• Extension Hose with a Flow Indicator, a Spike to pierce the Filler Bag Septum Port and a Blue Stopcock to connect to the Delivery Catheter.• A Syringe that, if needed, can be connected to the Delivery Catheter and used to evacuate the Balloon in an emergency.
Allurion Technologies, Inc.
2026-04-07
Allurion™ Stylet - The Allurion Stylet is comprised of the following items:- A Stylet shaft with proximal connector. The Stylet, if needed, can be inserted into the Delivery Catheter to assist patient in swallowing the Device.
Allurion Technologies, Inc.
2026-04-07