The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Zeltiq Coolsculpting System.
| Device ID | K181740 |
| 510k Number | K181740 |
| Device Name: | ZELTIQ CoolSculpting System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Contact | Ewald Riechert |
| Correspondent | Alex Chang ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive 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 | 2018-07-02 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816417020114 | K181740 | 000 |
| 00816417021626 | K181740 | 000 |
| 00816417021503 | K181740 | 000 |
| 00816417021497 | K181740 | 000 |
| 00816417021473 | K181740 | 000 |