CoolSculpting Elite System— 510(k) K212707

Substantially Equivalent

Zeltiq Aesthetics, Inc.

FDA 510(k) clearance K212707 for CoolSculpting Elite System, Substantially Equivalent on 2021-11-05. Applicant: Zeltiq Aesthetics, Inc..

Clearance details

Applicant: Zeltiq Aesthetics, Inc.
Product code: Code OOK
Advisory panel: General, Plastic Surgery
Date received: 2021-08-26
Decision date: 2021-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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.