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14 FDA 510(k) clearances · Product code

119 daysmedian time to decision
296 days90th percentile
14clearances measured

FDA profile

Official device name
Dermal Cooling Pack/Vacuum/Massager
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4340
Medical specialty
General, Plastic Surgery
FDA definition
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.
Adverse events (MAUDE)
2021: 1,161 · 2022: 1,978 · 2023: 5,499 · 2024: 1,277 · 2025: 916 · 2026: 370
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CoolSculpting Elite System (K233732)Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics2024-09-12
CoolSculpting Elite System (K212707)Zeltiq Aesthetics, Inc.2021-11-05
ZELTIQ CoolSculpting System (K193566)Zeltiq Aesthetics, Inc.2020-01-21
ZELTIQ CoolSculpting System (K183514)Zeltiq Aesthetics, Inc.2019-01-14
ZELTIQ CoolSculpting System (K181740)Zeltiq Aesthetics, Inc.2018-08-29
CoolSculpting System (K172144)Zeltiq Aesthetics2017-11-01
ZELTIQ CoolSculpting System (K171069)Zeltiq Aesthetics, Inc.2017-07-07
ZELTIQ CoolSculpting System (K162050)Zeltiq Aesthetics, Inc.2016-11-21
ZELTIQ CoolSculpting System (K160259)Zeltiq Aesthetics, Inc.2016-03-23
ZELTIQ CoolSculpting System (K151179)Zeltiq Aesthetics, Inc.2015-09-22
ZEL TIQ CoolSculpting System (K142491)Zeltiq Aesthetics, Inc.2015-01-26
ZELTIQ COOLSCULPTING SYSTEM (K133212)Zeltiq Aesthetics, Inc.2014-04-09
ZELTIQ COOLSCULPTING (K120023)Zeltiq Aesthetics, Inc.2012-05-02
ZELTIQ AESTHETICS DERMAL COOLING DEVICE (DEN090002)Zeltiq Aesthetics2010-08-24

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Every clearance here is in the API, with alerts when new ones post.