510(k) Report

FDA applicant

Medical Laser Systems, Inc.

Washington, DC2 decisions2007–20080 recalls

FDA records 2 decisions for Medical Laser Systems, Inc. (Washington, DC) from 2007 to 2008: 2 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and NHN (Powered Light Based Laser Non-Thermal…). Its devices cite 6 predicates, 0 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Laser Systems, 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?

  • ILYLamp, Infrared, Therapeutic Heating1decision
  • NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive…1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 20081cites it

What has FDA decided for it lately?

  • K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
  • K063574Luminex LL Laser SystemMedical Laser Systems, Inc. · 2007

All 2 as Medical Laser Systems, Inc. →