# K201801: Rapid Acoustic Pulse Device

- Pathway: 510(k) (Traditional)
- Applicant: Soliton, Inc.
- Decided: Jan 29, 2021 after 213 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: 2 generations back to K091537 (2009). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102541: Cynosure Cellulaze Laser, Cynosure, Inc. (2012) Summary page 4.

## Most influential descendants
- K223237: SofWave System (2022), 7 descendants of its own
- K230019: SofWave System (2023), 6 descendants of its own
- K230820: SofWave System (2023), 5 descendants of its own
- K232455: SofWave System (2023), 4 descendants of its own
- K240687: SofWave System (2024), 3 descendants of its own

## Indications for use
The Rapid Acoustic Pulse Device (RAP) 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 RAP device is also indicated for short-term improvement in the appearance of cellulite.

Source page: https://510kreport.com/device/K201801
Methodology: https://510kreport.com/methodology