Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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 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 Soliton Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments for tattoo removal. The RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits. The RAP is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the tattoo to be removed, penetrates the skin to the typical depth of tattoo ink. The RAP is a modification to the company's Acoustic Wave Device (AWD) that has already been cleared for the same indications for use (K190542). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.
Summary parsed at:2026-06-01 05:47:50 UTC
