ZELTIQ CoolSculpting System— 510(k) K181740
Substantially EquivalentZeltiq Aesthetics, Inc.
FDA 510(k) clearance K181740 for ZELTIQ CoolSculpting System, Substantially Equivalent on 2018-08-29. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code OOK
view allMore clearances from Zeltiq Aesthetics, Inc.
view allAdverse events under product code OOK
product code OOK- Injury
- 10,813
- Total
- 10,813
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K181740
K-number listed on FDA's recall record- Z-1346-2022 — CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
- Z-1347-2022 — CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
- Z-1348-2022 — CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
- Z-1349-2022 — CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
- Z-1350-2022 — CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181740.
Data sourced from openFDA. This site is unofficial and independent of the FDA.