Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The 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 long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.
The 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 long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.
The Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Handpiece and the replaceable Cartridge. The Console supplies saline to the Handpiece to enable formation of the shock wave within the acoustic pulse chamber. The Handpiece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent window of the Cartridge and acoustic ultrasound gel or similar hydrogel pad, which is placed against the surface of the skin to be treated. The subject Resonic device is identical to the previously cleared Resonic device. No changes have been made to the technological characteristics of the subject device to accommodate the update of indication for use.
Summary parsed at:2026-06-01 05:27:07 UTC
Resonic Rapid Acoustic Pulse Device
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