510(k) Report

FDA applicant

Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics

Pleasanton, CA1 decision2024–20240 recalls

FDA records 1 decision for Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics (Pleasanton, CA) in 2024: 1 510(k) clearance. All are in product code OOK (Dermal Cooling Pack/Vacuum/Massager). 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zeltiq Aesthetics, Inc. (Acquired by…’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 “Zeltiq”

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