Cynosure Lutronic said its laser device, CLARITY II, has received an expanded indication from Health Canada for hair removal treatment, further broadening its application scope.
With this latest approval, CLARITY II now holds four indications in Canada, adding hair removal to its existing approvals for pseudofollicular barbae, port-wine stain, and congenital melanocytic nevus.
Launched in 2019, CLARITY II is the successor to Lutronic's popular CLARITY Pro and features a dual-wavelength platform that incorporates a 1,064nm Nd:YAG laser and a 755nm Alexandrite laser.
The device is equipped with innovative technologies such as intelligent tracking, which ensures consistent laser beam overlap during procedures, and temperature sensing, which monitors the skin's surface temperature in real time and automatically halts the laser if it exceeds a safe threshold.
Cynosure and Lutronic, which merged in April last year, have since solidified their position as the world's leading energy-based device (EBD) medical company.
Headquartered in Westford, Massachusetts, the combined entity has completed its organizational integration and is strengthening its presence in the North American market. A significant change in Canada includes the transition from a distributor-based sales model to a direct sales operation, which has driven notable growth in revenue for strategic products like CLARITY II.
In addition to CLARITY II, Cynosure Lutronic launched the XERF radiofrequency (RF) device in May last year, leveraging the combined expertise of both companies in the medical device field.
"CLARITY II is currently approved in 39 countries, including the U.S. through FDA 510(k) clearance and CE certification in Europe," a Cynosure Lutronic representative said. "We are committed to ongoing research and investment in our product lineup to enhance skin health for patients globally, as demonstrated by the recent expansion of indications for CLARITY II."
