FDA applicant
Visioncare Devices, Inc.
FDA records 6 decisions for Visioncare Devices, Inc. (Redding, CA) from 1991 to 2022: 6 510(k) clearances. Most are in product codes HQE (Instrument, Vitreous Aspiration And Cutting…) and HQC (Unit, Phacofragmentation). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Visioncare Devices, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Visioncare Devices, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Visioncare Devices, Inc.’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) Report