510(k) Report

FDA applicant

Eclipsemed Global, Inc.

Dallas, TX2 decisions2010–20100 recalls

FDA records 2 decisions for Eclipsemed Global, Inc. (Dallas, TX) in 2010: 2 510(k) clearances. Most are in product codes ONG (Powered Laser Surgical Instrument With…) and ONF (Powered Light Based Non-Laser Surgical…). Its devices cite 3 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 Eclipsemed Global, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Eclipsemed Global, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K100487Equinox CO2 Laser SystemEclipsemed Global, Inc. · 20101cites it

What has FDA decided for it lately?

  • K100487Equinox CO2 Laser SystemEclipsemed Global, Inc. · 2010
  • K093465Fusion SystemEclipsemed Global, Inc. · 2010

All 2 as Eclipsemed Global, Inc. →