510(k) Report

FDA applicant

Microvision, Inc.

Seabrook, NH4 decisions1998–20030 recalls

FDA records 4 decisions for Microvision, Inc. (Seabrook, NH) from 1998 to 2003: 4 510(k) clearances. Most are in product codes LXP (Plug, Scleral) and FFS (Image, Illumination, Fiberoptic, For Endoscope). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Microvision Incorporated”.

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 Microvision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microvision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Microvision, 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?

  • LXPPlug, Scleral1decision
  • FFSImage, Illumination, Fiberoptic, For Endoscope1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • HQXImplant, Orbital, Extra-Ocular1decision

Whose devices does it build on?

Its devices cite 8 predicates; 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.

  • K982462Fiber Optic Endoillumination ProbeMicrovision, Inc. · 19981cites it
  • K030940Nomad ND1000M Augmented Vision SystemMicrovision Incorporated · 20031cites it

What has FDA decided for it lately?

  • K030940Nomad ND1000M Augmented Vision SystemMicrovision Incorporated · 2003
  • K022186Scleral Plugs, 19 and 20 GaugeMicrovision, Inc. · 2003
  • K023481Microvision Scleral Buckling ComponentsMicrovision, Inc. · 2003
  • K982462Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998

All 3 as Microvision, Inc. →The one decision as Microvision Incorporated →