510(k) Report

FDA applicant

Bonasse Ent. Co., Ltd.

Great Neck, NY1 decision2000–20000 recalls

FDA records 1 decision for Bonasse Ent. Co., Ltd. (Great Neck, NY) in 2000: 1 510(k) clearance. All are in product code LRX (Case, Contact Lens). 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 Bonasse Ent. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bonasse Ent. Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bonasse Ent. Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LRXCase, Contact Lens1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991206Bonasse Contact Lens CaseBonasse Ent. Co., Ltd. · 20003cite it

What has FDA decided for it lately?

  • K991206Bonasse Contact Lens CaseBonasse Ent. Co., Ltd. · 2000

The one decision as Bonasse Ent. Co., Ltd. →