The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc with the FDA for Zeltiq Coolsculpting System.
| Device ID | K162050 |
| 510k Number | K162050 |
| Device Name: | ZELTIQ CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics, Inc 4698 Willow Road Pleasanton, CA 94588 |
| Contact | Shruti Jayakumar |
| Correspondent | Shruti Jayakumar ZELTIQ Aesthetics, Inc 4698 Willow Road Pleasanton, CA 94588 |
| Product Code | OOK |
| CFR Regulation Number | 878.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-11-21 |
| Summary: | summary |