The First FDA Claims…
In 1986, LPG Technology was introduced in the U.S. Immediately, LPG Systems began the long, difficult process of obtaining FDA market clearance for LPG medical devices.
LPG Systems presented the FDA with Vanderbilt and UCLA clinical studies, which provided overwhelming proof of efficacy. The result? LPG Class I devices were granted the first ever FDA clearance for cellulite reduction and inch loss.
What You Don’t Know Can Hurt You – And Your Patients.
Since that watershed event, other companies have used LPG Systems hard wrought market clearance to list their devices with the FDA. Among them are Class II laser devices. 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- with a slight omission. LPG Systems devices, although definitively the first, are Class I - not Class II. That distinction is important – and one we’re proud of.
Why May Class II Devices Be Risky?
- Class II laser devices are not considered as safe by the FDA as LPG Systems 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, they use radiofrequency, which has been linked to major health problems like cancer, birth defects and severe neurological disorders.
- Class II laser devices with FDA clearance for cellulite and inch loss got them – not from the invasive laser component – but from the non-invasive therapeutic massage (that mimics LPG’s Class I devices). In fact, some FDA experts argue that lasers have no impact on cellulite and body contour at all - and that the risks far outweigh any benefits.
Ultimately, you must decide what is best for you - and your patients. If you decide to ignore the risk and get a Class II device, make sure you get liability insurance. You may need it.
What Must You Know?
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