Syneron-Candela has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Profound device when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as supported by long term data (six months).
Profound is a minimally invasive, fractional radiofrequency (RF) microneedling device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Its 25º Dermal handpiece and cartridge are used for percutaneous treatment of facial wrinkles, and the 75º SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III. A recent multicenter clinical study showed improvement of cellulite severity (in dimples and undulation irregularities) in 94% of treated thighs at three months by blinded review. Sustained improvement was observed at six months in 93% of treated thighs.
“This new FDA clearance provides a new treatment opportunity for patients with minimal discomfort and downtime,” said Philippe A. Schaison, CEO of Syneron-Candela North America. “We are thrilled to be able to add to our portfolio a long term solution to improve the appearance of cellulite that is complementary to our existing products.”
The company plans to release the product in 2017.