Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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 short-term improvement in the appearance of cellulite.
The Soliton ResonicTm 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 1-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.
The Soliton ResonicTM Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console. 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 skin to be treated. The Resonic RAP is a modification to the company's Rapid Acoustic Pulse (RAP) device that has already been cleared for the same indications for use (K201801). 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 05:42:57 UTC
