FDA Approval Status for Aluma

The dermatology product known as Aluma is commonly used as a noninvasive treatment for wrinkles. The design process for Aluma rests on the design of other similar products that are called "predicate devices" within the industry. Some users describe Aluma as a radio frequency-based technology. It uses electrodes to treat the skin and helps the body to strategically develop collagen to fight the formation of wrinkles in the outer layers of the skin. Aluma is promoted as a "nonsurgical" rejuvenation method to help users look younger.

Is Aluma Approved By the FDA?

Industry sources claim that Aluma was approved by the FDA in October of 2005. An internal FDA memorandum verifies that the FDA has deemed the products safe for marketing based on its similarity to predicate devices. A letter sent by the FDA to the makers of Aluma clears the company to market the product and cites proper adherence of the company's application to the standard process for screening substances and devices for the American market.

Although the 2005 documentation clears Aluma for interstate commerce, newer and emerging FDA documents may provide more insight on acceptable risks related to this product. Consult a physician before using Aluma or any similar product.

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