U.S. FDA Clearance for Two Pigmented Lesion Treatments

Two technological approaches to the treatment of pigmented lesions have gained FDA clearance. These are Syneron Medical’s PicoWay® picosecond laser and DEKA’s Synchro REPLA:Y family of Laser Systems offers high-speed, effective and safe treatment of benign pigmented lesions, wrinkles and photocoagulation of dermatological vascular lesions.


Israel’s Syneron Medical Ltd., is a global market leader in the aesthetic medical device marketplace. It’s PicoWay picosecond laser received FDA clearance for the removal of tattoos in November 2014 and incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink or pigmentation, leading to the new clearance for this indication.

Company comments

Amit Meridor, Chief Executive Officer of Syneron Medical, said, “The expansion of PicoWay’s FDA clearance to include pigmented lesions further enhances the utility of the system, allowing practitioners to offer this next-generation technology for more of their pigment-related procedures. It is also indicative of our commitment to add new applications that leverage the PicoWay technology for other treatments. Since launching the product late last year, there has been strong interest in PicoWay and we expect the addition of the pigmented lesion indication will further enhance its attractiveness to customers.”


DEKA M.E.L.A is a a leading developer and distributor of a wide range of light-based aesthetic systems. Its Synchro REPLA:Y® family of Laser Systems allows for unprecedented Maximum Power of 180W and a 24 mm spot size, the largest available in the industry. Specifically the Excellium 3.4 model is the most powerful and fastest platform available with utility for effective, safe and rapid hair reduction, on all Fitzpatrick skin types and tanned skin, including photocoagulation of vascular and treatment of benign pigmented lesions and wrinkles.

Physician comments

“The Synchro REPLA:Y, with 180W of maximum power and the largest available spot size of 24mm, is the fastest in the industry. The REPLA:Y’s extreme versatility and the multiple hand pieces allow me to split the beam and the pulse to micro tune the treatment to each patient’s needs. Due to the uniqueness of the pulse shape, the treatment, even at a speed of 3 pulses per second, is less painful than the one I can deliver with other lasers and quite tolerable. I am thrilled to be the first hair reduction specialist in North America to employ such a novel device in my business,” said Chris Karavolas, President of New York State Association of Laser Hair Removal Specialists; Founding Board Member of the International Association of Laser Aesthetics (IALA); Owner of “Romeo & Juliette Laser Hair Removal Center,” New York, NY.


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