Zdrowie i gospodarka · 11/06/1997

FDA Proposes to Reclassify Tweezer-Type Epilator from Class III to Class I for Hair Removal

The FDA is proposing to reclassify the tweezer-type epilator from a Class III device to a Class I device, which is intended for removing hair, and also proposes to exempt it from premarket notification requirements, based on new information and under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.