510(k) Report

FDA applicant

Usa Laser Biotech, Inc.

Houston, TX6 decisions2004–20160 recalls

FDA records 6 decisions for Usa Laser Biotech, Inc. (Houston, TX) from 2004 to 2016: 6 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 18 predicates, 6 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 Usa Laser Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2009: 12011: 12016: 2
2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Usa Laser Biotech, 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 Heating6decisions

Whose devices does it build on?

Its devices cite 18 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp…Usa Laser Biotech, Inc. · 20115cite it
  • K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 20053cite it
  • K042256IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo…Usa Laser Biotech, Inc. · 20042cite it
  • K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 20091cites it

What has FDA decided for it lately?

  • K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
  • K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System…Usa Laser Biotech, Inc. · 2016
  • K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp…Usa Laser Biotech, Inc. · 2011
  • K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 2009
  • K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005
  • K042256IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo…Usa Laser Biotech, Inc. · 2004

All 6 as Usa Laser Biotech, Inc. →