FDA 510(k) Applications for Medical Device Product Code "OOK"
| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K172144 |
ZELTIQ Aesthetics |
CoolSculpting System |
11/01/2017 |
| DEN090002 |
ZELTIQ AESTHETICS |
ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
08/24/2010 |
| K162050 |
ZELTIQ Aesthetics, Inc |
ZELTIQ CoolSculpting System |
11/21/2016 |
| K212707 |
Zeltiq Aesthetics, Inc. |
CoolSculpting Elite System |
11/05/2021 |
| K142491 |
ZELTIQ AESTHETICS, INC. |
ZEL TIQ CoolSculpting System |
01/26/2015 |
| K120023 |
ZELTIQ AESTHETICS, INC. |
ZELTIQ COOLSCULPTING |
05/02/2012 |
| K181740 |
ZELTIQ Aesthetics, Inc. |
ZELTIQ CoolSculpting System |
08/29/2018 |
| K183514 |
ZELTIQ Aesthetics, Inc. |
ZELTIQ CoolSculpting System |
01/14/2019 |
| K193566 |
ZELTIQ Aesthetics, Inc. |
ZELTIQ CoolSculpting System |
01/21/2020 |
| K171069 |
ZELTIQ Aesthetics, Inc. |
ZELTIQ CoolSculpting System |
07/07/2017 |
| K133212 |
ZELTIQ AESTHETICS, INC. |
ZELTIQ COOLSCULPTING SYSTEM |
04/09/2014 |
| K151179 |
ZELTIQ AESTHETICS, INC. |
ZELTIQ CoolSculpting System |
09/22/2015 |
| K160259 |
ZELTIQ AESTHETICS, INC. |
ZELTIQ CoolSculpting System |
03/23/2016 |
| K233732 |
ZELTIQ Aesthetics, Inc. (acquired by Allergan Aesthetics |
CoolSculpting Elite System |
09/12/2024 |
|
|