FDA Product Code
FDA Product Code OOK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4340
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024-09-12 | Traditional | PDF ↗ |
| K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | 2021-11-05 | Special | PDF ↗ |
| K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020-01-21 | Special | PDF ↗ |
| K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019-01-14 | Special | PDF ↗ |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2018-08-29 | Traditional | PDF ↗ |
| K172144 | CoolSculpting System | Zeltiq Aesthetics | 2017-11-01 | Traditional | PDF ↗ |
| K171069 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2017-07-07 | Traditional | PDF ↗ |
| K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-11-21 | Traditional | PDF ↗ |
| K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-03-23 | Traditional | PDF ↗ |
| K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-09-22 | Traditional | PDF ↗ |
| K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-01-26 | Traditional | PDF ↗ |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | Zeltiq Aesthetics, Inc. | 2014-04-09 | Traditional | PDF ↗ |
| K120023 | ZELTIQ COOLSCULPTING | Zeltiq Aesthetics, Inc. | 2012-05-02 | Traditional | PDF ↗ |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2010-08-24 | Post-NSE | — |
Product code OOK · Class II · General, Plastic Surgery. Data: openFDA.