Soliton’s Cellulite Reduction Device Application Accepted by FDA

The FDA has accepted Soliton’s 510(k) premarket clearance submission for the second generation version of its Rapid Acoustic Pulse device for cellulite reduction.

The device was previously cleared by the agency as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal.

The new application is supported by results from a clinical trial in which the device significantly reduced cellulite in a single 20-to-30-minute treatment.