DEKA Medical Receives FDA Clearance for the Synchro REPLA:Y
The FDA cleared DEKA Medical, Inc.'s Synchro REPLA:Y, an aesthetic workstation dedicated, but not limited, to high speed stable long-term, or permanent hair reduction, treatment of PFB, treatment of benign pigmented lesions, treatment of wrinkles and photocoagulation of dermatological vascular lesions.
The Synchro REPLA:Y by DEKA Medical combines hair removal on all Fitzpatrick skin types, including tanned skin, vascular and benign pigmented lesions treatments, as well as skin rejuvenation, in a single platform. Utilizing three different light sources: a 755nm Alexandrite laser, a 1064nm Nd:YAG laser, and an intense pulsed light, the Synchro REPLA:Y enables physicians to offer a broad range of treatments with efficacy, speed, and safety, according to the company.
The Synchro REPLA:Y anticipates the future, including for the first time in one system one powerful (125 W) and fast (3 Hz, while the industry standard is still 2 Hz) Alexandrite laser, together with one powerful (150 W) and fast Nd:YAG laser with unrivaled characteristics. Both lasers feature a wide range of spot sizes: from 2.5 mm to 20 mm. The intense pulsed light features 5 filters (from 500 nm to 650 nm lower cut-off wavelength), easily interchangeable, to allow a broad range of effective and safe treatments.
According to DEKA, while Alexandrite is universally recognized as the most effective laser source for hair reduction in fair skins, the Nd:YAG laser is the most widely used for treating dark skins. In addition, the the Synchro REPLA:Y's Alexandrite laser source can deliver energetic pulses with pulse length from 2 ms, down to 0.2 ms for skin rejuvenation and pigmented lesions treatment.
"As a double board certified dermatologist, international educator and lecturer on lasers and energy based devices, it is my business to know about emerging technologies. At conferences around the world, during laser courses and even in my own office, I am constantly asked about various technologies. In searching for the very best devices for my own patients, I evaluate many variables, including safety and efficacy and the technical specifications are fairly important in the evaluation process, too. The Synchro REPLA:Y by DEKA offers two wavelengths and an intense pulsed light hand piece. The energies, varying pulse widths and pulse shape and the large (20 mm) spot sizes represent an advancement in technology, that results in faster, better tolerated, and more reliable treatments. I am very excited to be the first dermatologist in North America to use the Synchro REPLA:Y and to offer its benefits to my patients" said Martin Kassir, MD, FAAD, Double Board Certified in Dermatology & Internal Medicine, Fellow ASLMS, Director of Kassir Dermatology in Dallas, TX.
The Synchro REPLA:Y is being distributed in North America exclusively by Cutting Edge Aesthetics, LLC, a wholly owned subsidiary of Cutting Edge Products, LLC.