510(k) Report

FDA applicant

Medical Options, Inc.

Carlsbad, CA1 decision1994–19940 recalls

FDA records 1 decision for Medical Options, Inc. (Carlsbad, CA) in 1994: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Medical Options, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Options, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Options, 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?

  • GEXPowered Laser Surgical Instrument1decision

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.

  • K943543Medical Optics CO2 Surgical Laser SystemsMedical Options, Inc. · 19941cites it

What has FDA decided for it lately?

  • K943543Medical Optics CO2 Surgical Laser SystemsMedical Options, Inc. · 1994

The one decision as Medical Options, Inc. →