510(k) Report

FDA applicant

Paradigm Trex, LLC

San Diego, CA1 decision2002–20020 recalls

FDA records 1 decision for Paradigm Trex, LLC (San Diego, CA) in 2002: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Paradigm Trex, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Paradigm Trex, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Paradigm Trex, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

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 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.

  • K014253Dermachiller 4Paradigm Trex, LLC · 20023cite it

What has FDA decided for it lately?

  • K014253Dermachiller 4Paradigm Trex, LLC · 2002

The one decision as Paradigm Trex, LLC →

Other applicant names beginning “Paradigm”

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

Paradigm Spine, LLC 16Paradigm Medical Industries, Inc. 10Paradigm Medical, Inc. 3Paradigm Lasers, Inc. 1