FDA applicant

Ulthera, Inc.

Mesa, AZ14 decisions2009–20261 recall

FDA records 14 decisions for Ulthera, Inc. (Mesa, AZ) from 2009 to 2026: 13 510(k) clearances and 1 De Novo grant. Most are in product codes OHV (Focused Ultrasound For Tissue Heat Or…) and OUP (Powered Surgical Instrument For Improvement In…). Its devices cite 15 predicates, 13 of them its own earlier devices. 1 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 Ulthera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2009high 2 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2016

2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Ulthera, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ulthera, Inc.

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?

What has been recalled?