Sep 3 2007
Candela Corporation today announced that it received an additional FDA clearance for the Serenity™ device using Pneumatic Skin Flattening (PSF™) technology. This clearance enables the use of the Serenity™ device for the reduction of pain during all laser and intense pulse light (IPL) treatments. According to Millennium Research, the worldwide installed base of laser and IPLs is estimated to be 70,000 worldwide.
Gerard E. Puorro, President and Chief Executive Officer, said, “We are pleased to announce the receipt of this additional FDA approval for our innovative PSF™ technology, which we obtained through our acquisition of Inolase last March. This clearance is a significant milestone in the roll-out of the PSF™ technology and enables us to further implement this technology across a wide range of applications and devices.”
“Patients often discontinue their aesthetic laser treatments because of pain. The PSF™ technology relies on the Gate theory for pain reduction which inhibits the transmission of pain signals to the brain, making treatments more tolerable and thus, improving outcomes,” said Nicole M. Shugrue, Senior Product Marketing Manager at Candela. “The expanded product claim will allow practitioners to differentiate their aesthetic practice and improve patient retention by offering this device as an adjunct to their entire laser and intense pulse light aesthetic treatment platform.”
Eric F. Bernstein, M.D., Laser Surgery and Cosmetic Dermatology Centers, Bryn Mawr, PA, who performed some of the studies leading to FDA clearance stated, "The Serenity™ device with the PSF™ technology has enabled treatment of patients who otherwise were unable to tolerate laser and IPL treatments because of pain. In my practice I have seen a significant increase in patient volume because of this device.”