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Spa Machine Safety
By: Christine Heathman
Posted: June 26, 2008, from the July 2008 issue of Skin Inc. magazine.
page 4 of 9
Important to this statement is, if you have invested in a skin care machine that falls outside the regulatory guidelines, a recall could impact your business. You should weigh if this is worth the risk before choosing a skin care machine to purchase.
Regulations based on technology
Individual technologies are unique. Responsible regulation must weigh product benefits against product risks. In all instances, upholding client safety and improving lives comes first, so, recognizing the diversity and complexity of devices, the FDA tailored the following review system to be appropriate for the individual pieces of equipment.
Always ask what class the device you are being sold falls into. Based on experience and observation, if a skin device does not have an active FDA classification, you should definitely be asking yourself about the actual effectiveness of the appliance.
The three-tiered class system allows the FDA to appropriately match the level of review with the individual device and has become the model for machine technology regulation worldwide, an interesting caveat given that many foreign manufacturers sell their skin devices in the United States.
Class I covers simple devices, such as microdermabrasion and low-dose ultrasound, that generally do not need premarket studies. However, many companies committed to the sciences do take this additional step. Class I devices pose a very low risk and account for approximately 30% of all devices on the market.