OOK · Class II · 21 CFR 878.4340

FDA Product Code OOK: Dermal Cooling Pack/vacuum/massager

The Device Is A Combination Of A Cooling Pad Associated With A Vacuum Or Mechanical Massager Intended For The Disruption Or Induction Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.

Leading manufacturers include Zeltiq Aesthetics, Inc., Zeltiq Aesthetics and Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics.

14
Total
13
Cleared
124d
Avg days
2010
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dermal Cooling Pack/vacuum/massager Devices (Product Code OOK)

14 devices
1–14 of 14
Cleared Sep 12, 2024
CoolSculpting Elite System
K233732
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
General & Plastic Surgery · 296d
Cleared Nov 05, 2021
CoolSculpting Elite System
K212707
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 71d
Cleared Jan 21, 2020
ZELTIQ CoolSculpting System
K193566
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 29d
Cleared Jan 14, 2019
ZELTIQ CoolSculpting System
K183514
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 27d
Cleared Aug 29, 2018
ZELTIQ CoolSculpting System
K181740
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 58d
Cleared Nov 01, 2017
CoolSculpting System
K172144
Zeltiq Aesthetics
General & Plastic Surgery · 107d
Cleared Jul 07, 2017
ZELTIQ CoolSculpting System
K171069
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 88d
Cleared Nov 21, 2016
ZELTIQ CoolSculpting System
K162050
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 119d
Cleared Mar 23, 2016
ZELTIQ CoolSculpting System
K160259
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 51d
Cleared Sep 22, 2015
ZELTIQ CoolSculpting System
K151179
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 141d
Cleared Jan 26, 2015
ZEL TIQ CoolSculpting System
K142491
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 144d
Cleared Apr 09, 2014
ZELTIQ COOLSCULPTING SYSTEM
K133212
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 173d
Cleared May 02, 2012
ZELTIQ COOLSCULPTING
K120023
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 120d
Not Cleared Aug 24, 2010
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
DEN090002
Zeltiq Aesthetics
General & Plastic Surgery · 315d

About Product Code OOK - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code OOK since 2010, with 13 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.