K183514 is an FDA 510(k) clearance for the ZELTIQ CoolSculpting System. This device is classified as a Dermal Cooling Pack/vacuum/massager (Class II - Special Controls, product code OOK).
Submitted by Zeltiq Aesthetics, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 14, 2019, 27 days after receiving the submission on December 18, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4340. 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..
| 510(k) Number | K183514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2018 |
| Decision Date | January 14, 2019 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OOK - Dermal Cooling Pack/vacuum/massager |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4340 |
| 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. |