Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.

Inclusion criteria

• Female ages 18-50 years
• Seeking treatment of cellulite in the thigh and/or buttock areas
• Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
• Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
• Stable weight nominally +/- 5% for at least the past 6 months.
• Body Mass Index (B.M.I.) is ≤ 30
• Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
• Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
• Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
• Participant is willing to participate in study and adhere to follow-up schedule
• Participant is able to read and comprehend English
• Participant has completed the Informed Consent Form

Exclusion criteria

• Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
• Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
• Participant is pregnant or planning to become pregnant during the duration of the study.
• Has atrophic scars, or has a history of atrophic scars or keloids.
• Tattoo or former tattoo at or near treatment area.
• Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
• Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
• Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
• History of coagulopathy(ies) and/or on anticoagulant medication.
• Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
• Current smoker.
• Any surgical procedure in the prior 3 months, or planned during the duration of the study.