510(k) Report

FDA applicant

Visioncare Devices, Inc.

Redding, CA6 decisions1991–20220 recalls

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, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Visioncare Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Visioncare Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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