# K212502: Resonic Rapid Acoustic Pulse Device

- Pathway: 510(k) (Traditional)
- Applicant: Soliton, Inc.
- Decided: Nov 5, 2021 after 88 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: 4 generations back to K091537 (2009). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210964: Resonic Rapid Acoustic Pulse Device, Soliton, Inc. (2021) Summary page 4.

## Most influential descendants
- K222629: Resonic Rapid Acoustic Pulse Device (2022), 1 descendant of its own
- K233804: Resonic Rapid Acoustic Pulse Device (2024), 0 descendants of its own

## Indications for use
The Soliton 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 1 year of observation.

Source page: https://510kreport.com/device/K212502
Methodology: https://510kreport.com/methodology