Silk'n(TM) Personal Light-Based Hair Removal Device Cleared By FDA

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Mar 2008 - 5:00 PDT

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Home Skinovations Ltd. announced that the Silk'n™ device was cleared by the United States Food and Drug Administration (FDA) for home-based removal of unwanted hair under the direction of a physician. Silk'n™, powered by the innovative and proprietary Home Pulsed Light™ technology (HPL™), is clinically tested and physician approved for safe, quick, and effective removal of hair by patients in the convenience of their home. Silk'n™ will be available exclusively through physicians.

The efficacy and safety of Silk'n™ was tested in a multi-center clinical study involving 4 medical centers in North America and Israel over the last 12 months. A total of 150 patients self treated with Silk'n™ in physicians' offices as part of the study, and the initial hair count as well as the post-treatment hair count of these patients was monitored by the investigating physicians.

An average reduction of 50% in the hair count was monitored three months post three bi-weekly treatment sessions. No adverse effects were noted in the course of the study, and the users of Silk'n™ recorded an extremely high level of satisfaction with the device and their results.

Home Skinovations will be launching Silk'n™ into the US market in Booth 339 at the 2008 American Society of Laser Medicine & Surgery (ASLMS) annual meeting to be held in Kissimmee, Florida from April 2nd to 6th. A clinical study on Silk'n™ conducted by Dr. Tina Alster titled "The Effect of a Novel Low-Energy, Pulsed Light Device for Home-Use Hair Removal" will be presented as part of the ASLMS scientific program on April 6th at 10:40 a.m.

Dr. Tina Alster, who is an internationally acclaimed dermatological laser specialist, is quoted as saying: "In the clinical studies I conducted with Silk'n™, I was impressed with the device's efficacy, safety and ease of use. I look forward to offering Silk'n™ as an essential component of my hair removal practice."

Additionally Dr. Jerome Garden who also participated in clinical studies with Silk'n™ has said: "In studies at my practice, patients were able to safely, easily, and effectively treat themselves with Silk'n™. In follow-up surveys, patients reported satisfaction from the use of Silk'n™."

"Silk'n™ is poised to significantly alter the manner in which physicians and home-based patients treat and manage hair removal results," noted Thomas Goslau, Vice President of Marketing & Sales for Home Skinovations. He further stated that, "as a physician-directed device, Silk'n™ will enable physicians to maintain and even maximize their share of one of the most highly requested aesthetic procedures in the US today, all the while offering their patients the convenience and comfort of carrying out hair removal treatments in the comfort of their own homes."

Home Skinovations is a private company founded in Israel in June, 2006, with a mission to develop, manufacture and sell the safest and most effective home-use aesthetic devices. The company was founded by a skilled team of scientists, engineers and industry executives with a successful track record for introducing innovative light-based and laser products to the global aesthetic devices market. The company's patent pending core Home Pulsed Light™ technology (HPL™) brings nearly two decades of advancements in light and laser technology together in a pulsed-light system designed exclusively for safe and effective aesthetic treatments by doctors' patients at home. Besides offering a superior solution for long-term removal of unwanted hair, the company's HPL™ technology can treat a variety of other aesthetic applications such as Acne and Skin Rejuvenation.

Silk'n