510(k) Report

FDA applicant

Leica Microscopy Systems, Ltd.

Great Neck, NY1 decision2000–20000 recalls

FDA records 1 decision for Leica Microscopy Systems, Ltd. (Great Neck, NY) in 2000: 1 510(k) clearance. All are in product code HEX (Colposcope (And Colpomicroscope)). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Leica Microscopy Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leica Microscopy Systems, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leica Microscopy Systems, 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?

  • HEXColposcope (And Colpomicroscope)1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K000707Leica ColposcopeLeica Microscopy Systems, Ltd. · 20002cite it

What has FDA decided for it lately?

  • K000707Leica ColposcopeLeica Microscopy Systems, Ltd. · 2000

The one decision as Leica Microscopy Systems, Ltd. →

Other applicant names beginning “Leica”

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

Leica Biosystems Newcastle, Ltd. 6Leica Biosystems Imaging, Inc. 5Leica Microsystems (Schweiz) AG 4Leica, Inc. 3Leica Microsystems, Inc. 2Leica Biosystems 1Leica Microsystems, Inc. O.I.D. 1Leica Biosystems Richmond 1