FDA applicant
Alcon Universal, Ltd.
FDA records 5 decisions for Alcon Universal, Ltd. (Fort Worth, TX) from 2000 to 2002: 5 510(k) clearances. Most are in product codes LPN (Accessories, Soft Lens Products) and MRC (Products, Contact Lens Care, Rigid Gas Permeable). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 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 Universal, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Alcon Universal, Ltd. since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Alcon Universal, Ltd.’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.