Allurion Technologies, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Allurion Technologies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LTI | Implant, Intragastric For Morbid Obesity | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250023 | PMA | Allurion Gastric Balloon System | 2026-02-20 |
Recalls
openFDA lists no recalls under a recalling firm named Allurion Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Allurion Technologies, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05368259: The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY) (Active not recruiting, started 2022-05-12)
- NCT05884606: The Allurion Digital Behaviour Change Intervention (Completed, started 2021-06-19)
- NCT03261453: THE ENLIGHTEN STUDY (Completed, started 2018-02-01)
SEC filings
ALLURION TECHNOLOGIES, INC. (ALUR, ALURW): EDGAR filings, CIK 1964979. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Allurion Technologies, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Allurion Technologies, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Allurion Technologies, Inc.?
The most frequent FDA product codes under this applicant name are LTI (Implant, Intragastric For Morbid Obesity, 1).
Next steps
- See all 0 Allurion Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LTI, Allurion Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.