510(k) Report

FDA applicant

American Optisurgical, Inc.

Lake Forest, CA6 decisions1995–20103 recalls

FDA records 6 decisions for American Optisurgical, Inc. (Lake Forest, CA) from 1995 to 2010: 6 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 5 predicates, 1 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 American Optisurgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2009: 12012: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like American Optisurgical, Inc.’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?

  • HQCUnit, Phacofragmentation5decisions
  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K101561TX1 Tissue Removal SystemAmerican Optisurgical, Inc. · 20101cites it
  • K020527Horizon Phacoemulsification System, Model HZN-2030American Optisurgical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K101561TX1 Tissue Removal SystemAmerican Optisurgical, Inc. · 20102 recalls
  • K080803Visual Phacoemulsification System, Model 551American Optisurgical, Inc. · 2008
  • K020527Horizon Phacoemulsification System, Model HZN-2030American Optisurgical, Inc. · 20021 recall
  • K953538RM001 ReusableAmerican Optisurgical, Inc. · 1995
  • K953539DM001 Disposable PackAmerican Optisurgical, Inc. · 1995
  • K952331Aoi LC-40 PhacoemulsifierAmerican Optisurgical, Inc. · 1995

All 6 as American Optisurgical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K101561American Optisurgical's TX1 Tissue Removal System Console. The console is a software…Mar 30, 2013Class II
  • K101561TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic…Feb 22, 2012Class II
  • K020527American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for…Mar 24, 2009