FDA applicant
Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
FDA records 2 decisions for Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (Fort Worth) from 1995 to 2014: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LZS (Excimer Laser System) and OOE (Ophthalmic Femtosecond Laser). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alcon Research, Ltd. Dba Alcon Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alcon Research, Ltd. Dba Alcon…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Alcon”
FDA records each applicant name separately; these may or may not be the same firm.