Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Soliton Acoustic Wave Device (AWD) is indicated for use as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.
The Soliton Acoustic Wave Device (AWD) is indicated for use as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.
The Soliton Acoustic Wave Device (AWD) is designed as an accessory to laser treatments for tattoo removal. The AWD 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 Soliton AWD 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 shape, frequency and repetition rate of these acoustic waves are optimized to diffuse gas bubbles (vacuoles) caused by the use of a Q-switched laser without damaging adjacent non-pigmented tissue. Removing them by using the Soliton AWD allows another Q-switched laser treatment to be performed immediately instead of waiting for the body to remove the gas pockets and heal over a period of 4-6 weeks between standard laser treatments.
Summary parsed at:2026-06-01 05:55:12 UTC
