510(k) Report

FDA applicant

Intraoptics Surgical, Inc.

Irvine, CA1 decision1990–19900 recalls

FDA records 1 decision for Intraoptics Surgical, Inc. (Irvine, CA) in 1990: 1 510(k) clearance. All are in product code HQC (Unit, Phacofragmentation). 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 Intraoptics Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intraoptics Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intraoptics Surgical, Inc. 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?

  • HQCUnit, Phacofragmentation1decision

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.

  • K902876Phacotron Systems Plus Iii Phacoemulsifier Aspi.Intraoptics Surgical, Inc. · 19901cites it

What has FDA decided for it lately?

  • K902876Phacotron Systems Plus Iii Phacoemulsifier Aspi.Intraoptics Surgical, Inc. · 1990

The one decision as Intraoptics Surgical, Inc. →

Other applicant names beginning “Intraoptics”

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

Intraoptics, Inc. 1