FDA Expands Indications for Syneron Medical Skin Treatment Laser

Irvine, Calif.-based Syneron Medical Ltd., an aesthetic device maker, has earned expanded indications from the U.S. Food and Drug Administration (FDA) for its CO2RE CO2 device. This clearance, including more than 90 specific indications in total, significantly expands the business opportunity for CO2RE users for high patient demand treatments. The new indications for use include gynecology applications (including vaginal treatments), wrinkles, scars, and a wide range of dermatology and plastic surgery indications.

CO2RE incorporates proprietary advanced scanner technology, high peak power and a high brightness CO2 laser. A previously FDA-cleared version of the device was initially launched in 2010. The CO2RE is currently sold in more than 50 countries. CO2RE is a CO2 laser offering multi-depth pulse technology, delivering precisely fractionated beam patterns to treat two layers of the epidermis and dermis simultaneously. This precision technology creates areas of superficial and deep ablation and coagulation to activate remodeling at several tissue depths. This same technology presents advantages in treatment of several body areas in addition to the demonstrated performance of the aesthetic treatments.

“This broad range of newly FDA cleared clinical indications of the CO2RE will enable Syneron Candela to address new physician markets with very high patient demand and creates a significant business opportunity for the company, including new modalities and applications for dermatology, plastic surgery and gynecology treatments that will be introduced to the market soon,” said Amit Meridor, CEO of Syneron Candela.

“For my practice, we selected the CO2RE CO2 device because it is so versatile with traditional and fractional resurfacing which means we can treat a wide range of conditions,” said Hayes Gladstone, M.D., a dermatologic surgeon. “Adding it to our practice has been easy. It has an excellent graphic interface, as well as a small footprint, and has expanded our patient offerings.”