LPG Endermologie Medical Devices: FDA Clearance and FDA Approval.

The U.S. Food and Drug Administration carefully monitors medical devices, so you know what’s safe for your medi-spa clients - and what’s not. If you’re thinking of investing in skincare, spa or medical equipment, it’s imperative that you find out how the product stands with the FDA.

As explained in the July 2008 issue of Skin Inc., you want to make sure that “your new asset falls in line with the US Food and Drug Administration (FDA) and is backed by scientific research and documentation – not just marketing hype.”

With today’s economy and the competitive landscape of beauty, you’ll need a point of difference, and if you choose wisely, the right device can do it for you. To find out if it’s the real deal or a ‘cheap knock-off look-alike machine,’ you’ll need to do your homework.

According to Skin Inc., “there are thousands of skin machines currently on the market not registered with the FDA, and yet they are marketed as ‘regulated’ by the organization, piggybacking on the credibility of trustworthy and honorable companies that have gone to the expense of following regulations and abiding by the law.” Do LPG Endermologie Treatments and Technologies have that FDA credibility?

Yes. Immediately after our US debut, we underwent the long, difficult process of getting FDA market clearance. But it paid off. Vanderbilt and UCLA clinical studies landed LPG the first-ever FDA clearance for cellulite and inch loss. That was in 1997 and 1998.

But what about the piggybacking – has that happened to LPG? Unfortunately, yes. Other companies piggybacked on LPG’s hard wrought market clearance to list their devices with the FDA. Among them are Class II laser devices like Syneron’s Velasmooth and Cynosure’s TriActive. Some of these laser manufacturers even assert that they’re the first to attain market clearance for cellulite reduction and inch loss. It’s true – but with a major omission.

LPG Endermologie devices, although definitively the first, are Class I - not Class II. Class II laser devices are not considered as safe by the FDA as LPG’s Class I devices. The FDA perceives the more invasive Class II devices as posing a greater risk to patients. Besides the risk of injury and scarring, these laser devices use radiofrequency, which has been linked to major health problems like cancer, birth defects and severe neurological disorders. So as a Class 1, LPG Endermologie devices have the highest FDA ratings for safety possible.

And here’s the other interesting tidbit: Class II laser devices with FDA clearance for cellulite and inch loss have it - not from the invasive laser component – but from the non-invasive therapeutic massage. Yes, the one that attempts to mimic LPG’s Class I devices. Some FDA experts go so far as to argue that lasers have little if any impact on cellulite and body contour at all - and that the risks far outweigh any benefits.

That’s why Endermologie is still #1 in the world for cellulite and body contouring. It can’t be beat.

If you have an LPG Endermologie machine, you’re much more competitive in today’s dynamic marketplace. Here’s what’s included in LPG Endermologie machines FDA clearance:

• Temporarily* reduces the appearance of cellulite and circumferential body measurements of cellulite treated areas
• Temporarily improves local blood circulation
• Relieves DOMS (Delayed Onset Muscle Soreness)
• Relieves minor muscle aches and pains
• Relieves muscle spasms
• Relieves minor muscle aches and pains, relieves muscle spasms, and improves local circulation during burn rehabilitation*
• Reduction of secondary lymphedema of the arm (SLA) post mastectomy*
• Improvement of secondary lymphedema*
• Improvement of lymphatic circulation in the treated area*

* Why “Temporarily”?
This term refers not to the limitations of the technique or technology, but to the natural physiological changes of the body. Nothing lasts forever because the body is constantly evolving. To preserve results – regular treatments are needed. But with continued treatments, long-lasting results are possible with LPG.

Today, more than 85 clinical investigations have scientifically validated the reliability, efficacy, and safety of LPG Endermologie Technology for a wide array of treatment applications. For more information on these studies, visit www.cosire-lpg.com. To purchase LPG Technologies, call Techno-Derm, the exclusive US distributor at 888-892-4588.