510(k) Report

FDA applicant

Ophtec USA, Inc.

Boca Raton, FL2 decisions2001–20030 recalls

FDA records 2 decisions for Ophtec USA, Inc. (Boca Raton, FL) from 2001 to 2003: 2 510(k) clearances. Most are in product codes NCE (Injector, Capsular Tension Ring) and HNQ (Hook, Ophthalmic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ophtec, USA”.

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 Ophtec USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ophtec USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ophtec USA, 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?

  • NCEInjector, Capsular Tension Ring1decision
  • HNQHook, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K030471Ophtec Enclavation NeedleOphtec, USA · 2003
  • K011498Easy Control Micro Inserter, Model ON385Ophtec USA, Inc. · 2001

The one decision as Ophtec USA, Inc. →The one decision as Ophtec, USA →

Other applicant names beginning “Ophtec”

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

Ophtec BV 2