The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Coolsculpting Elite System.
| Device ID | K212707 |
| 510k Number | K212707 |
| Device Name: | CoolSculpting Elite System |
| Classification | Dermal Cooling Pack/vacuum/massager |
| Applicant | Zeltiq Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Contact | Vicky Chai |
| Correspondent | Vicky Chai 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 | 2021-08-26 |
| Decision Date | 2021-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816417022746 | K212707 | 000 |