The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Zeltiq Coolsculpting System.
| Device ID | K193566 |
| 510k Number | K193566 |
| Device Name: | ZELTIQ CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Contact | Tammy Wharton |
| Correspondent | Tammy Wharton 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 | 2019-12-23 |
| Decision Date | 2020-01-21 |