Monday, March 24, 2008
Silk'n Hair Removal System FDA Approved
Filed under: Plastic Surgery
Israeli company Home Skinovations Ltd. has received FDA approval to market its Silk'n hair removal system, a device that works via company's proprietary light therapy, dubbed Home Pulsed Light™ (HPL™). Designed to be used by the patient, but with physician guidance, the system promises both efficacy and privacy.
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.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.
Press release: Silk'n™ Personal Light-Based Hair Removal Device Cleared by FDA
Product page: Silk'n
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