FDA applicant

Zeltiq Aesthetics, Inc.

Pleasanton, CA17 decisions2008–20246 recalls

FDA records 17 decisions for Zeltiq Aesthetics, Inc. (Pleasanton, CA) from 2008 to 2024: 16 510(k) clearances and 1 De Novo grant. Most are in product codes OOK (Dermal Cooling Pack/Vacuum/Massager) and GEX (Powered Laser Surgical Instrument). Its devices cite 24 predicates, 20 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Zeltiq Aesthetics”.

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 Zeltiq Aesthetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008high 2 (2015) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

5in 2022

2008high 5 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Zeltiq Aesthetics, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zeltiq Aesthetics, Inc.’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

Other applicant names beginning “Zeltiq”

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

Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics 1

Zeltiq Aesthetics, 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?

Other applicant names beginning “Zeltiq”