510(k) Report

FDA applicant

Technological Medical Advancments, Inc. (Tma)

West Palm Beach, FL1 decision2012–20121 recall

FDA records 1 decision for Technological Medical Advancments, Inc. (Tma) (West Palm Beach, FL) in 2012: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). 1 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 Technological Medical Advancments, Inc. (Tma)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2012high 1 (2026) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Technological Medical Advancments, Inc. (Tma) by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K121363Diowave Low Level Cold Laser SystemTechnological Medical Advancments, Inc. (Tma) · 20123cite it

What has FDA decided for it lately?

  • K121363Diowave Low Level Cold Laser SystemTechnological Medical Advancments, Inc. (Tma) · 20121 recall

The one decision as Technological Medical Advancments, Inc. (Tma) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K121363Diowave Laser System, REF: Diowave 250WJan 9, 2026Class II