510(k) Report

FDA applicant

Exeltis USA Dermatology, LLC

Florham Park, NJ1 decision2017–20170 recalls

FDA records 1 decision for Exeltis USA Dermatology, LLC (Florham Park, NJ) in 2017: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 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

How often FDA has decided Exeltis USA Dermatology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Exeltis USA Dermatology, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K170911NEOCERA Advanced Barrier CreamExeltis USA Dermatology, LLC · 2017

The one decision as Exeltis USA Dermatology, LLC →