510(k) Report

FDA applicant

Ophthocare, Ltd.

Ramat-Gan, IL1 decision2005–20050 recalls

FDA records 1 decision for Ophthocare, Ltd. (Ramat-Gan, IL) in 2005: 1 510(k) clearance. All are in product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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 Ophthocare, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ophthocare, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ophthocare, 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?

  • HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K050856LCG (Liquide Crystal Glasses) SystemOphthocare, Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050856LCG (Liquide Crystal Glasses) SystemOphthocare, Ltd. · 2005

The one decision as Ophthocare, Ltd. →