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.

FILED UNDER: COSMETIC/AESTHETIC, FOOD & DRUG ADMINISTRATION (FDA), REGULATORY/COMPLIANCETAGGED WITH: HIRONIC