510(k) Report

FDA applicant

Diomedics, Inc.

Gainesville, FL3 decisions1993–20080 recalls

FDA records 3 decisions for Diomedics, Inc. (Gainesville, FL) from 1993 to 2008: 3 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and FTC (Light, Ultraviolet, Dermatological). 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 Diomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Diomedics, 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
  • FTCLight, Ultraviolet, Dermatological1decision
  • GEXPowered Laser Surgical Instrument1decision

Who builds on its devices?

Later devices cite its devices 7 times; 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.

  • K982546Phaser-2000Diomedics, Inc. · 19987cite it

What has FDA decided for it lately?

  • K073503Versa LiteDiomedics, Inc. · 2008
  • K982546Phaser-2000Diomedics, Inc. · 1998
  • K926224Diomedics Surgi Light/Light Touch Optical FibersDiomedics, Inc. · 1993

All 3 as Diomedics, Inc. →