Syneron Candela Announces New FDA Clearance for the CO2RE System

November 4, 2015

The FDA has granted numerous additional indications for use of Syneron Medical Ltd.’s 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.

Hayes Gladstone, MD, a dermatologic surgeon said, "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.  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."

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