The following data is part of a premarket notification filed by Zeltiq Aesthetics with the FDA for Coolsculpting System.
| Device ID | K172144 |
| 510k Number | K172144 |
| Device Name: | CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics 4410 Rosewood Road Pleasanton, CA 94588 |
| Contact | Ewald Riechert |
| Correspondent | Ewald Riechert ZELTIQ Aesthetics 4410 Rosewood 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 | 2017-07-17 |
| Decision Date | 2017-11-01 |
| Summary: | summary |