The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Zeltiq Coolsculpting System.
| Device ID | K133212 |
| 510k Number | K133212 |
| 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 | 2013-10-18 |
| Decision Date | 2014-04-09 |
| Summary: | summary |