510(k) Report

FDA applicant

Eclipse Aesthetics, LLC

Dallas, TX2 decisions2013–20130 recalls

FDA records 2 decisions for Eclipse Aesthetics, LLC (Dallas, TX) in 2013: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONG (Powered Laser Surgical Instrument With…). Its devices cite 2 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 Eclipse Aesthetics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Eclipse Aesthetics, LLC by year, 2013–2026Sources: 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 Instrument1decision
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 20131cites it

What has FDA decided for it lately?

  • K131903Equinox CO2 LaserEclipse Aesthetics, LLC · 2013
  • K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC · 2013

All 2 as Eclipse Aesthetics, LLC →

Other applicant names beginning “Eclipse”

FDA records each applicant name separately; these may or may not be the same firm.

Eclipse Medcorp, LLC 4Eclipse Systems, Inc. 2Eclipse, Inc. 1Eclipse Ventures 1