# K233804: Resonic Rapid Acoustic Pulse Device

- Pathway: 510(k) (Traditional)
- Applicant: Zeltiq Aesthetics, Inc.
- Decided: Feb 1, 2024 after 64 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K091537 (2009). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222629: Resonic Rapid Acoustic Pulse Device, Zeltiq Aesthetics, Inc. (2022) Summary page 4.

## Indications for use
The Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q- Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.

Source page: https://510kreport.com/device/K233804
Methodology: https://510kreport.com/methodology