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Data / Medical devices / United States / Allurion Technologies, Inc.

Allurion Technologies, Inc.: FDA-registered device maker in Natick, MA, United States, 1 PMA approval

Allurion Technologies, Inc. is registered with the FDA (registration 3011299930) in Natick, MA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 20, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011299930
Address
11 Huron Dr, Natick, MA, United States, 01760
Owner or operator
Allurion Technologies, Inc. (10047966)
Roles
Manufacturer
First device listed
March 27, 2026
Registered through
2026
Brand names listed
Allurion Gastric Balloon System

Devices it lists

DeviceProduct codeClassRoleSource
Implant, Intragastric For Morbid ObesityLTI3Manufactureraccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 20, 2026P250023Allurion™ Gastric Balloon SystemLTI2September 23, 2026accessdata.fda.gov

Compare with other makers

Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.