FDA applicant
Alcon Laboratories
FDA records 116 decisions for Alcon Laboratories (Fort Worth, TX) from 1976 to 2026: 90 510(k) clearances and 26 original PMA approvals. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPN (Accessories, Soft Lens Products). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 140 predicates, 43 of them its own earlier devices. 37 recalls are linked to its devices.
FDA’s records also spell it “Alcon Laboratories, Inc.”, “Alcon Laboratories, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alcon Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Alcon Laboratories’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.