FDA expands indications for Syneron Candela’s CO2 laser device

The FDA has granted additional indications for the use of Syneron Candela’s CO₂ laser device, according to a press release.

The clearance includes more than 90 specific indications in total for the CO₂RE system, which includes propriety advanced scanner technology, high peak power and a high brightness CO2 laser, according to the release from Syneron Medical Ltd. New indications include wrinkles, scars, a wide range of dermatology and plastic surgery indications, and gynecology applications, including vaginal treatments.

Hayes B. Gladstone

“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,” Hayes B. Gladstone, MD, a dermatologic surgeon and founder and president of president of the Gladstone Clinic, San Ramon, Calif, stated in the release.

The FDA previously cleared a version of the CO₂RE device in 2010, which is now sold in more than 50 countries, according to the release. The device offers multi-depth pulse technology, which delivers fractionated beam patterns to two layers of the epidermis and dermis simultaneously, creating areas of superficial and deep ablation and coagulation, the release stated.

“This broad range of newly FDA cleared clinical indication 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 market soon,” Amit Meridor, chief executive officer of Syneron Candela, stated in the release.

Reference: www.syneron.com