510(k) Report

FDA applicant

Hoya Corp. USA

Lake Success, NY1 decision1994–19940 recalls

FDA records 1 decision for Hoya Corp. USA (Lake Success, NY) in 1994: 1 510(k) clearance. All are in product code HLM (Instrument, Measuring, Lens, Ac-Powered). No recall is linked to its devices.

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 Hoya Corp. USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hoya Corp. USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Hoya”

FDA records each applicant name separately; these may or may not be the same firm.