www.fdanews.com/articles/202579-soliton-earns-additional-fda-clearance-for-rapid-acoustic-pulse-device
Soliton Earns Additional FDA Clearance for Rapid Acoustic Pulse Device
May 3, 2021
Soliton has received additional FDA 510(k) clearance for Resonic, a rapid acoustic pulse (RAP) device, clearing modifications that improve its use.
The device includes a new autoloading cartridge for the RAP system and an improved user interface. The product delivers rapid pulses of acoustic shockwaves to assist lasers in skin-related treatments.
The RAP device first received clearance for tattoo removal in May 2019. This was followed by 510(k) clearance for treating cellulite in February 2021.