The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Zeltiq Coolsculpting System.
| Device ID | K183514 |
| 510k Number | K183514 |
| Device Name: | ZELTIQ CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Contact | Katherine Prendergast |
| Correspondent | Katherine Prendergast ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Product Code | OOK |
| CFR Regulation Number | 878.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-01-14 |
| Summary: | summary |