Syneron Candela Achieves Approval to Market Its ALEX II System in Japan

04/29/2014

Syneron Medical Ltd.'s 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 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.

"In comparison to Q-switched ruby lasers and Q-switched Nd:YAG lasers, which are also commonly used in Japan, I believe that Candela's Q-switched alexandrite laser is well-balanced in clinical use. It has an optimal wavelength and pulse duration to obtain high efficacy while reducing the risk of complications, especially hypopigmentation, during the course of treatment," said Dr. Taro Kono, Associate professor, Department of Plastic and Reconstructive Surgery, Tokai University.

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, according to the company. 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.

 

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