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I sought information from the company that sells DermaWand regarding whether or not it had FDA approval after noticing that I was developing more lip lines after I had started using the product. My concern was that though the DermaWand might provide for a temporary appearance of skin tightening right after using it, when discontinued for even a short time, the damage becomes clear by the appearance of more lines. I think it may actually be breaking down the skin fibers but that this isn't noticeable until after you stop using it. I contacted the company to question whether this product had been tested and received FDA approval. The answer was that because it wasn't a medication, that it wasn't required and the answer was no, it had not been approved by the FDA. It is not only medications that are tested by the FDA. Years ago certain air purifiers were removed from the market because they produced ozone and the levels had not been approved by the FDA. I would not recommend this product!