The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Zeltiq Coolsculpting System.
| Device ID | K171069 |
| 510k Number | K171069 |
| Device Name: | ZELTIQ CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics, Inc. 4410 Rosewood Road Pleasanton, CA 94588 |
| Contact | Shruti Jayakumar |
| Correspondent | Ewald Riechert ZELTIQ Aesthetics, Inc. 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 | 2017-04-10 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816417021206 | K171069 | 000 |
| 00816417021190 | K171069 | 000 |