Tentech Inc., a medical device company, has completed initial shipment of the monopolar RF treatment device '10THERMA' to the U.S. and is going to enter the U.S. market in earnest. This follows the '510(K) Clearance' for 10THERMA received from the U.S. Food and Drug Administration (FDA) late last year.
According to Tentech Inc., “The first shipment of 10THERMA in the U.S. is set to be managed and sold through BENEV, Tentech's partner in the U.S.”

BENEV Company Inc., established in California in 2000 and now a partner with Tentech Inc,, is an FDA-registered pharmaceutical manufacturer specializing in medical devices and clinical products. BENEV’s products are distributed globally through a hospital network. Last June, Tentech Inc. signed a contract valued at approximately 7.26 million U.S. dollars (about 10 billion KRW, with an exchange rate of 1,378 KRW = 1 USD).

10THERMA is a 6.78MHz monopolar RF treatment device with a maximum output of 400W. It delivers RF energy to the dermis, generating heat through the skin's electrical resistance. The 5㎠ face tip is wider than those of other RF devices, allowing for 25% more energy coverage per shot. 10THERMA features an S.T.C. (Smart Temperature Cooling) system, which emits a total of seven cooling pulses during shot. Additionally, 10THERMA is equipped with impedance matching technology that helps adjust precise targeted energy for individuals.

Mr. Han, CEO of Tentech Inc., emphasized, “As 10THERMA’s entry into the U.S. market gains momentum, collaborating with our local partner, BENEV, will help trigger rapid penetration into the U.S. market.