Fans of home-use diode systems for skin rejuvenation may be excited to learn that the newest product in home skin care is being readied for manufacture and distribution. However, there is also reason to be extremely cautious. Read on to find out why.
About the Tanda Skin Rejuvenation System
The Tanda Skin Rejuvenation System is a new at-home laser skin product from aesthetic device company Syneron Medical Ltd.
According to Syneron, the Tanda Skin Rejuvenation System utilizes light therapy to deliver younger-looking skin. It is designed for the diminishment of wrinkles and fine lines in the area surrounding the eye, called the periorbital region. The device relies on a proprietary super luminous LED (light-emitting diode) that discharges concentrated channels of light to achieve its phototherapy effect. Syneron alleges that this new device is five times more powerful than the current Tanda product family, thereby lowering the necessary number of treatments to two per week.
In early January, Syneron announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to manufacture and market its new product.
501k Approval: What Exactly Does It Mean?
Essentially, a 501(k) approval means that the FDA has accepted documentation submitted by the company, in this case Syneron, that demonstrates a device is safe and effective and has given the company the green light to market the product.
Though the Tanda Skin Rejuvenation system has been given 501(k) approval, there are some factors to consider before jumping on board. First, a 501(k) clearance does not necessarily mean a product is 100% safe. Many products with this type of clearance are not tested by the FDA directly. That’s because a rule devised to speed up the approval process permits the FDA to grant clearance based on the past approval of a similar device, comparable to judicial system rulings. It is possible that the Tanda Skin Rejuvenation System went through this type of process.
In addition, there are many examples of a product receiving FDA clearance only to be recalled later on by the manufacturer due to dangerous mishaps.
Without further information on the approval process for the Tanda Skin Rejuvenation System, Healthy Skin Portal recommends taking extreme precaution before attempting the use of any home-care LED system.
When Will The Tanda Be Available?
Syneron is arranging to begin commercialization of the new Tanda skin rejuvenation product in the latter half of 2011 in professional and consumer markets alike. Pricing of the Tanda skin rejuvenation System is not yet known.
Skin Rejuvenation Alternatives
For those who do not want to wait until the Tanda is released, or are looking for skin rejuvenation alternatives, there are many other viable options to consider, such as Botox, microdermabrasion, or professional laser skin rejuvenation.
To learn more or to schedule a free skin care consultation with a cosmetic specialists in your area, contact Healthy Skin Portal today.
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