# K200331: Rapid Acoustic Pulse Device

- Pathway: 510(k) (Special)
- Applicant: Soliton, Inc.
- Decided: Mar 10, 2020 after 29 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: 3 generations back to K950019 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190542: Soliton Acoustic Wave Device, Soliton, Inc. (2019) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K200331
Methodology: https://510kreport.com/methodology