510(k) Report

FDA applicant

Medical Illumination International, Inc.

San Fernando, CA5 decisions2001–20140 recalls

FDA records 5 decisions for Medical Illumination International, Inc. (San Fernando, CA) from 2001 to 2014: 5 510(k) clearances. Most are in product codes FST (Light, Surgical, Fiberoptic) and FSY (Light, Surgical, Ceiling Mounted). Its devices cite 8 predicates, 1 of them its own earlier devices. 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 Illumination International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12014: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Illumination International, 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?

  • FSTLight, Surgical, Fiberoptic2decisions
  • FSYLight, Surgical, Ceiling Mounted1decision
  • LBIUnit, Neonatal Phototherapy1decision
  • FSSLight, Surgical, Floor Standing1decision

Whose devices does it build on?

Its devices cite 8 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.

  • K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 20101cites it
  • K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next…Medical Illumination International, Inc. · 20011cites it

What has FDA decided for it lately?

  • K140812MI-750 Procedural/Minor Surgical LightMedical Illumination International, Inc. · 2014
  • K10038821ST Century Centurion Exceled and System Two Led Lighting SystemsMedical Illumination International, Inc. · 2010
  • K053227Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights, Spotlights, Refractors and…Medical Illumination International, Inc. · 2006
  • K010495Centura Phototherapy SpotlightMedical Illumination International, Inc. · 2001
  • K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next…Medical Illumination International, Inc. · 2001

All 5 as Medical Illumination International, Inc. →