OOK — Dermal Cooling Pack/Vacuum/Massager Class II
FDA product code OOK covers "Dermal Cooling Pack/Vacuum/Massager", a Class II medical device regulated under 21 CFR 878.4340. Submissions are reviewed by the General, Plastic Surgery panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OOK
- Device Class
- Class II
- Regulation Number
- 878.4340
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233732 | zeltiq aesthetics, inc. (acquired by allergan aesthetics | CoolSculpting Elite System | September 12, 2024 |
| K212707 | zeltiq aesthetics | CoolSculpting Elite System | November 5, 2021 |
| K193566 | zeltiq aesthetics | ZELTIQ CoolSculpting System | January 21, 2020 |
| K183514 | zeltiq aesthetics | ZELTIQ CoolSculpting System | January 14, 2019 |
| K181740 | zeltiq aesthetics | ZELTIQ CoolSculpting System | August 29, 2018 |
| K172144 | zeltiq aesthetics | CoolSculpting System | November 1, 2017 |
| K171069 | zeltiq aesthetics | ZELTIQ CoolSculpting System | July 7, 2017 |
| K162050 | zeltiq aesthetics | ZELTIQ CoolSculpting System | November 21, 2016 |
| K160259 | zeltiq aesthetics | ZELTIQ CoolSculpting System | March 23, 2016 |
| K151179 | zeltiq aesthetics | ZELTIQ CoolSculpting System | September 22, 2015 |
| K142491 | zeltiq aesthetics | ZEL TIQ CoolSculpting System | January 26, 2015 |
| K133212 | zeltiq aesthetics | ZELTIQ COOLSCULPTING SYSTEM | April 9, 2014 |
| K120023 | zeltiq aesthetics | ZELTIQ COOLSCULPTING | May 2, 2012 |
| DEN090002 | zeltiq aesthetics | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | August 24, 2010 |