Jeisys Medical

Jeisys Medical Co., Ltd. (CEO Kang Dong Hwan, hereinafter referred to as ‘Jeisys’) announced on August 14th that its aesthetic medical device 'DENSITY' has received FDA 510K approval from the U.S. Food and Drug Administration.

After receiving approval for its equipment and four types of medical device products from the Ministry of Food and Drug Safety (MFDS) in April, DENSITY was officially launched in the domestic market. DENSITY is a universal electrosurgical device that delivers high-frequency current to the skin, generating heat through skin electrical resistance to coagulate tissue. With this approval, Jeisys is now able to accelerate its entry into the North American market, including the United States. 

The key specifications of the FDA-approved DENSITY include △ maximum output of 400W △ two types of tips available: monopolar and bipolar continuous operation △ high-frequency current of 6.78MHz. It also features real-time impedance checking and skin temperature measurement functions to assist the operator in safely using the equipment, along with a cooling function with 5 levels to lower the tip temperature using cooling gas, consistent with the specifications of the product released domestically.

A Jeisys official stated “As a globally recognized manufacturer of K-medical devices, we are pleased to have demonstrated the safety and efficacy of our products through FDA approval.” He(or she) added, "With the launch of DENSITY and the significant interest it has garnered in the industry, we look forward to receiving great love and attention from the North American market."

Meanwhile, DENSITY, which began full-scale sales in June, is actively conducting marketing campaigns under the theme of "The lifting DENSITY personally chosen by Lee Young Ae," featuring actress Lee Young Ae as the model.
Advertisements for DENSITY can be seen on various TV channels, including terrestrial, cable, and satellite channels, as well as on outdoor billboards in major areas of Gangnam. Additionally, advertisements are displayed in dermatology clinics, on bus exteriors, and on various online platforms such as YouTube, Instagram, and Facebook.

Source: Jeisys Medical's 'DENSITY', US FDA 510K approval... Accelrating to entry into the North American market, Nave News, 18th Aug 2023