510(k) Report

FDA applicant

Diomed, Inc.

North Reading, MA8 decisions1999–20071 recall

FDA records 8 decisions for Diomed, Inc. (North Reading, MA) from 1999 to 2007: 8 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 16 predicates, 8 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Diomed, Ltd.”.

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 Diomed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Diomed, 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?

  • GEXPowered Laser Surgical Instrument8decisions

Whose devices does it build on?

Its devices cite 16 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 8 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.

  • K023543Evlt Kit and D15PLUS and D30PLUS DiodeDiomed, Inc. · 20028cite it
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 20026cite it
  • K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 20055cite it
  • K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 20044cite it
  • K013499Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc. · 20012cite it
  • K063828Diomed Delta 25Diomed, Ltd. · 20071cites it

What has FDA decided for it lately?

  • K063828Diomed Delta 25Diomed, Ltd. · 2007
  • K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
  • K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 20041 recall
  • K023543Evlt Kit and D15PLUS and D30PLUS DiodeDiomed, Inc. · 2002
  • K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002
  • K013499Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc. · 2001
  • K000982A100 Aesthetic Diode LaserDiomed, Inc. · 2000
  • K990014DioscanDiomed, Inc. · 1999

All 5 as Diomed, Inc. →All 3 as Diomed, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041957VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box…Aug 10, 2022Class II