The following data is part of a premarket notification filed by Zeltiq Aesthetics, Inc. with the FDA for Resonic Rapid Acoustic Pulse Device.
| Device ID | K222629 |
| 510k Number | K222629 |
| Device Name: | Resonic Rapid Acoustic Pulse Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zeltiq Aesthetics, Inc. (acquired Soliton, Inc. Through Parent Company AbbVie) 4410 Rosewood Drive Pleasanton, CA 94588 |
| Contact | Saurabh Jamkhindikar |
| Correspondent | Saurabh Jamkhindikar Zeltiq Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-31 |
| Decision Date | 2022-09-25 |