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Allurion Gastric Balloon System

by Allurion Technologies Inc. United States EUDAMEDPMA

PMA P250023Ref 10B Product code LTIEMDN G030601

Overview

The Allurion Gastric Balloon System is an intragastric implant designed to promote short-term weight loss in adults aged 22 to 65. It is indicated for individuals with a body mass index between 30 and 40 kg/m2 who have previously attempted weight loss programs without success.

This system is used in conjunction with a moderate intensity lifestyle modification therapy program. The treatment involves the placement of up to two balloons over a 10-month period, with an average observed residence time of 15.3 weeks per balloon. The device has received FDA PMA and MDD authorizations.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR PMA Approved NumberP250023 Date20 Feb 2026ApprovedStatusActive
European UnionCE/MDD EUDAMED NumberB-10B7B Basic UDI-DIDate18 Apr 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · PMA · synced 22 Oct 2026

Generic Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Model / Reference
10B
FDA applicant
Allurion Technologies, Inc.
Primary DI / UDI-DI
D-10B7B
Basic UDI-DI
B-10B7B
PMA Number
FDA Product Code
LTI
EMDN Code
G030601 Intragastric balloon systems
Device Class
Class IIb EUDAMED
Class III PMA
Market of Registration
France
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDPMA
Device ClassEUDAMED
Class IIb
PMA
Class III

From the manufacturer

Allurion Program: the world's first and only swallowable gastric balloon combined with expert nutrition support and comprehensive digital tools.

Source: allurion.com

Other devices from Allurion Technologies Inc.

Questions

  • Who is the Allurion Gastric Balloon System intended for?

    The system is intended for adults between 22 and 65 years old with a body mass index (BMI) between 30 and 40 kg/m2 who have previously participated in an unsuccessful weight loss program.

  • How long does the Allurion Gastric Balloon remain in the body?

    The residence time for each balloon is variable, with an average observed residence time of 15.3 weeks.

  • Is the Allurion Gastric Balloon used alone for weight loss?

    No, the system is designed to be used in conjunction with a moderate intensity lifestyle modification therapy program to support weight loss goals.

Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (10)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • FDA PMA P250023 24 fields · synced 22 Oct 2026
  • EUDAMED 6f1bdcfe-71f5-4549-86e5-515d7397fe5d 61 fields · synced 9 Jul 2026