Laser Facts by the FDA

Some laser hair removal companies in Houston may claim they have laser or IPL machines recommended by the FDA. But as we can see the FDA does not rate any laser/IPL system. Don't let them fouled you and make sure you look for FDA approved technology for laser hair removal treatments.

Here at Body Envy Houston we care about your results. And we know how important it is to feel confident and happy with your self image. Let us guide you through our services and help you find the body you have always wanted. Unbeatable affordability and luxury found at Body Envy Houston. We specialize in IPL / Hair Removal and Skin Rejuvenation. Visit www.bodyenvyhouston.com for more information.

Laser Facts

Medical lasers have been used for dermatology applications such as removal of port wine stains, dark spots, tattoos, acne scars and other blemishes for over a decade. Lasers are used for a growing number of cosmetic procedures including hair removal, treatment of wrinkles, and tooth whitening. For risk information on the specific laser treatment that you are considering, ask your physician or operator for the patient labeling for the laser device.

HAIR REMOVAL

The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's
Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.

Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices http://www.fda.gov/cdrh/consumer/laserfacts.html (1 of 2)9/26/2007 3:53:52 PM

Laser Facts does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to
demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair.

The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.

FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another. Lasers cleared for body hair removal are also cleared for facial hair removal.

FOR MORE INFORMATION GO TO: http://www.fda.gov/cdrh/consumer/laserfacts.html

Great Results with Palomar StarLux

State of the art Technology

In 1996, Palomar became the first light-based technology company to receive FDA clearance for Permanent Hair Reduction. Since then, we have continued to develop more powerful and effective technology to achieve the quickest possible hair clearance.

Pulsed Light hair removal works by emitting pulses of intense light into the hair follicles. The light is absorbed by the pigment in the follicles and converted to heat. The heat then loosens the hair and disables the cells responsible for growing new hair.

There are several reasons we have chosen to take on the enormous expense of this system for our clients. The Starlux is the latest technology available in the world for this industry. It uses IPL , which is an Intense Pulsed Light, to deliver specific wavelengths of filtered light clinically proven to de-activate hair follicles in their growth phase.

Starlux has the largest treatment head available. No other system can cover a larger surface area of the skin with one quick pulse.

The Starlux has two cooling systems to maximize the reliability, control and comfort of each treatment.

First, a heat absorbing sapphire crystal contacts the skin. The sapphire crystal protects the skin from becoming hot and uncomfortable. The crystal cools the skin before, during, and after the pulse of light.

Secondly, the Starlux uses a proprietary system that acts like the radiator of a car to guarantee that the cooling contact area is always comfortable.

This system gives a rapid hair reduction with less discomfort and less treatment time than pre-existing products and at a cost that is more affordable to the doctor and the patient. Go to: www.bodyenvyhouston.com for more information.