Syneron Medical has announced that its subsidiary in Japan, Candela KK, received registration approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its ALEX II system in Japan for the treatment of benign dermal lesions.
A special configuration of Candela’s successful Alex TriVantage platform that has been customized for the Japanese market, the ALEX II is a single wavelength Q-switched alexandrite laser designed to treat congenital pigmented lesions and tattoos.
It is the second generation of the 755nm Q-switched laser system popular in Japan for the treatment of pigmented lesions common to Japanese skin types. It features 2mm, 3mm and 4mm treatment spot sizes and is capable of delivering up to 18 J/cm2 fluence.
There are approximately 500 ALEXLAZR systems in Japan at the current time. Candela’s ALEX II is now poised to replace these with state-of-the-art technology that offers superior results.
Known to be an exacting process, approval from the MHLW will also facilitate health insurance payments to physicians and patients allowing for certain medical conditions to be reimbursed.
Patients with congenital pigmented lesions, such as Nevus of Ota, ectopic Mongolian spots and traumatic tattoos, will now be covered under Japan’s National Health Insurance (NHI). Physicians will receive reimbursement for every treatment that is spaced three months apart.
Candela KK president Toshio Mori noted that the company is honored that the ALEX II 755nm Q-switched laser system has been approved for use in Japan.
"This marks a significant milestone in our global distribution, as physicians and patients in Japan will now have greater access to the gold standard treatment that Candela’s ALEX II offers," Mori added.