Korea’s Hironic wins FDA nod for AFit laser acne device

Korean skin care device developer Hironic has won FDA approval for its AFit laser device intended to treat acne.

The AFit device features a 1450 nm diode laser designed to penetrated into the dermal and subcutaneous layers. The system also features a bipolar radiofrequency and Cryogen cooling device, the company said.

“AFit’s FDA approval has a great significance in that it has established a bridge for entry into the United States, which is the largest market in the global cosmetic medical device, with a share of nearly 50%. Other equipments that are under FDA approval will also be affected,” CEO Jinwoo Lee said in a press release.

Hironic said that it already won CE Mark approval in the European Union for its Double gold and Mi-Cool skin care devices.

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