ZEL TIQ CoolSculpting System— 510(k) K142491

Name: FDA 510(k) clearance K142491
Creator: U.S. Food and Drug Administration
Published: 2015-01-26

Substantially Equivalent

Zeltiq Aesthetics, Inc.

FDA 510(k) clearance K142491 for ZEL TIQ CoolSculpting System, Substantially Equivalent on 2015-01-26. Applicant: Zeltiq Aesthetics, Inc.. Device class: 2.

Clearance details

Applicant: Zeltiq Aesthetics, Inc.
Product code: Code OOK
Device class: Class 2
Regulation: 21 CFR 878.4340
Advisory panel: General, Plastic Surgery
Date received: 2014-09-04
Decision date: 2015-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K193566 — ZELTIQ CoolSculpting System2020-01-21
K183514 — ZELTIQ CoolSculpting System2019-01-14
K181740 — ZELTIQ CoolSculpting System2018-08-29

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K171069 — ZELTIQ CoolSculpting System2017-07-07
K162050 — ZELTIQ CoolSculpting System2016-11-21
K160259 — ZELTIQ CoolSculpting System2016-03-23

Adverse events under product code OOK

product code OOK

Injury: 10,813
Total: 10,813

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.