510(k) Report

FDA applicant

Fci Ophthalmics, Inc.

Marshfield Hills, MA13 decisions1996–20060 recalls

FDA records 13 decisions for Fci Ophthalmics, Inc. (Marshfield Hills, MA) from 1996 to 2006: 13 510(k) clearances. Most are in product codes OKS (Lacrimal Stents And Intubation Sets) and LZU (Plug, Punctum). 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 Fci Ophthalmics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fci Ophthalmics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fci Ophthalmics, Inc. 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?

  • OKSLacrimal Stents And Intubation Sets4decisions
  • LZUPlug, Punctum3decisions
  • HQXImplant, Orbital, Extra-Ocular2decisions
  • HPZImplant, Eye Sphere2decisions
  • MQUOcular Peg1decision
  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K061404Mono-Crawford Naso-Lacrimal Intubation DeviceFci Ophthalmics, Inc. · 20063cite it
  • K991238Fci Crawford Probe Intubation SetsFci Ophthalmics, Inc. · 19992cite it
  • K041869Self Retaining Bicanaliculus Intubation SetFci Ophthalmics, Inc. · 20042cite it

What has FDA decided for it lately?

  • K061404Mono-Crawford Naso-Lacrimal Intubation DeviceFci Ophthalmics, Inc. · 2006
  • K061398Snug Plug Punctum PlugFci Ophthalmics, Inc. · 2006
  • K041869Self Retaining Bicanaliculus Intubation SetFci Ophthalmics, Inc. · 2004
  • K023758Becker Transnasal Lacrimal (Intubation Sets)Fci Ophthalmics, Inc. · 2003
  • K023400Fci Mesh Wrapped Bioceramic Orbital ImplantFci Ophthalmics, Inc. · 2003
  • K030054Disposable Vitrectomy Sets, Disposable Virectomy LensesFci Ophthalmics, Inc. · 2003
  • K992294Bioceramic Orbital ImplantFci Ophthalmics, Inc. · 2000
  • K991238Fci Crawford Probe Intubation SetsFci Ophthalmics, Inc. · 1999

All 13 as Fci Ophthalmics, Inc. →