510(k) Report

FDA applicant

Amo Manufacturing USA, LLC

Milpitas, CA9 decisions1995–20233 recalls

FDA records 9 decisions for Amo Manufacturing USA, LLC (Milpitas, CA) from 1995 to 2023: 6 510(k) clearances and 3 original PMA approvals. Most are in product codes OOE (Ophthalmic Femtosecond Laser) and LZS (Excimer Laser System). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. 3 recalls are 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 Manufacturing USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12017: 12018: 12021: 12022: 12023: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2007: 12018: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • OOEOphthalmic Femtosecond Laser5decisions
  • LZSExcimer Laser System3decisions
  • GEXPowered Laser Surgical Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 83 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 20153cite it
  • K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 20181cites it
  • K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC · 20211cites it
  • K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 20171cites it

What has FDA decided for it lately?

  • K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC · 2023
  • K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC · 2022
  • K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC · 2021
  • K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 2018
  • K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC · 20171 recall
  • K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
  • P990010Visx Excimer Laser System Model C StarAmo Manufacturing USA, LLC · 1999
  • P930016Visx Excimer Laser System Models B and CAmo Manufacturing USA, LLC · 19962 recalls

All 9 as Amo Manufacturing USA, LLC →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P930016iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan…Oct 21, 2021Class II
  • K113479OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33…May 9, 2018Class II
  • P930016AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051Dec 13, 2007