FDA Clears Light-Based Skin Treatment Device

The U.S. FDA has cleared Deka Medical’s Synchro REPLA:Y®, an innovative 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.

Background

The U.S. combined demand for hair removal, pigmented lesion and vascular lesion removal is reportedly expected to increase 13.7 % from 2,111,400 treatments in 2013 to 2,445,900 treatments in 2014.

One of the device players is Deka Medical, Inc., developer and distributor of a wide range of light-based aesthetic systems designed to use laser light to achieve a number of skin treatments. In a press release, Deka Medical has announced the FDA clearance of its Synchro REPLA:Y device, which the company describes as offering a hair removal solution for all Fitzpatrick skin types, including tanned skin, vascular and benign pigmented lesions treatments, as well as skin rejuvenation, in a single platform.

According to Deka the secret lies in utilizing 3 different light sources: a 755 nm Alexandrite laser, a 1064 nm Nd:YAG laser and an intense pulsed light, and 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.

The company tells us that Alexandrite and Nd:YAG wavelengths are the most efficacious for hair reduction treatments, the former being the most effective laser source for hair reduction in fair skins, the latter being the most widely used for treating dark skins.

Physician comments

“The Synchro REPLA:Y is the fastest, most powerful laser, with one of the biggest spot sizes in the industry. The Synchro 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 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 removal 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.

“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 2 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 M.D., F.A.A.D., Double Board Certified in Dermatology & Internal Medicine, Fellow ASLMS, Director of “Kassir Dermatology”, Dallas, TX.

Source: Deka Medical, Inc., PR Newswire

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