OOK · Dermal Cooling Pack/Vacuum/Massager
General, Plastic Surgery · 21 CFR 878.4340 · Class 2
Overview
| Product Code | OOK |
|---|---|
| Device Name | Dermal Cooling Pack/Vacuum/Massager |
| Regulation | 21 CFR 878.4340 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.
Classification Rationale
Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | Sep 12, 2024 | SESE |
| K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | Nov 5, 2021 | SESE |
| K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 21, 2020 | SESE |
| K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 14, 2019 | SESE |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Aug 29, 2018 | SESE |
| K172144 | CoolSculpting System | Zeltiq Aesthetics | Nov 1, 2017 | SESE |
| K171069 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jul 7, 2017 | SESE |
| K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Nov 21, 2016 | SESE |
| K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Mar 23, 2016 | SESE |
| K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Sep 22, 2015 | SESE |
| K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | Jan 26, 2015 | SESE |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | Zeltiq Aesthetics, Inc. | Apr 9, 2014 | SESE |
| K120023 | ZELTIQ COOLSCULPTING | Zeltiq Aesthetics, Inc. | May 2, 2012 | SESE |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | Aug 24, 2010 | DENG |
Top Applicants
- Zeltiq Aesthetics, Inc. — 11 clearances
- Zeltiq Aesthetics — 2 clearances
- Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics — 1 clearance
