510(k) Report

FDA applicant

Amo Manufacturng USA, LLC

Milpitas, CA1 decision2020–20200 recalls

FDA records 1 decision for Amo Manufacturng USA, LLC (Milpitas, CA) in 2020: 1 510(k) clearance. All are in product code OOE (Ophthalmic Femtosecond Laser). 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 Amo Manufacturng USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Amo Manufacturng USA, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OOEOphthalmic Femtosecond Laser1decision

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 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.

  • K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC · 20202cite it

What has FDA decided for it lately?

  • K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC · 2020

The one decision as Amo Manufacturng USA, LLC →