510(k) Report

FDA applicant

Litecure, LLC

Newark, DE7 decisions2007–20180 recalls

FDA records 7 decisions for Litecure, LLC (Newark, DE) from 2007 to 2018: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 16 predicates, 2 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 Litecure, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12010: 12011: 12012: 22013: 12018: 1
2007high 2 (2012) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Litecure, LLC’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 Instrument3decisions
  • ILYLamp, Infrared, Therapeutic Heating3decisions
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision

Whose devices does it build on?

Its devices cite 16 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K070400LC Therapy, Model LCT-1000Litecure, LLC · 20072cite it
  • K123014Litecure Therapy System Model LTS-1500Litecure, LLC · 20131cites it

What has FDA decided for it lately?

  • K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018
  • K123014Litecure Therapy System Model LTS-1500Litecure, LLC · 2013
  • K123031BWF-5 Medical Laser SeriesLitecure, LLC · 2012
  • K121487Litecure Therapy CompactLitecure, LLC · 2012
  • K103511Litecure Therapy SystemLitecure, LLC · 2011
  • K093087BWF-5 Medical Laser SeriesLitecure, LLC · 2010
  • K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007

All 7 as Litecure, LLC →