510(k) Report

FDA applicant

Lynton Lasers Limited

Holmes Chapel, Cheshire, GB3 decisions2006–20070 recalls

FDA records 3 decisions for Lynton Lasers Limited (Holmes Chapel, Cheshire, GB) from 2006 to 2007: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 4 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, general and plastic surgery panel, where it files most

How often FDA has decided Lynton Lasers Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision

Whose devices does it build on?

Its devices cite 4 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.

  • K062871Lumacare LC-122M Non-Coherent Light SourceLynton Lasers Limited · 20061cites it

What has FDA decided for it lately?

  • K072048Lumacare Model LC-122M Non-Coherent Light Source and Model Lum-P Fibre Optic ProbeLynton Lasers Limited · 2007
  • K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited · 2007
  • K062871Lumacare LC-122M Non-Coherent Light SourceLynton Lasers Limited · 2006

All 3 as Lynton Lasers Limited →