510(k) Report

FDA applicant

Essilor Intl.

Hampshire, GB2 decisions2000–20040 recalls

FDA records 2 decisions for Essilor Intl. (Hampshire, GB) from 2000 to 2004: 2 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HLL (Monitor, Eye Movement). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Essilor Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Essilor Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Essilor Intl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear1decision
  • HLLMonitor, Eye Movement1decision

Whose devices does it build on?

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

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.

  • K003170Rythmic and Rythmic UVEssilor Intl. · 20001cites it

What has FDA decided for it lately?

  • K033949Varilux Visionprint System (VPS)Essilor Intl. · 2004
  • K003170Rythmic and Rythmic UVEssilor Intl. · 2000

All 2 as Essilor Intl. →

Other applicant names beginning “Essilor”

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

Essilor Of America, Inc. 1