FDA applicant

Lexington International, LLC

Washington, DC8 decisions2007–20180 recalls

FDA records 8 decisions for Lexington International, LLC (Washington, DC) from 2007 to 2018: 8 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Its devices cite 11 predicates, 8 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, physical medicine panel, where it files most

How often FDA has decided Lexington International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 4 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lexington International, LLC’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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Other applicant names beginning “Lexington”

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

Lexington Medical, Inc. 9 Lexington Industries 2 Lexington Instruments 1

Lexington International, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lexington”