FDA Warns Korean Hair Removal Device Mfr on Possible Refusal of Admission
The Food and Drug Administration has issued a warning letter to BNB Medical Co., Ltd. of Seoul, Korea regarding its manufacturing and marketing of BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair…
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Removal devices without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act, and are subject to refusal of admission under the FFDCA. FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.