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四环医药(00460.HK)独家代理的双波射频治疗仪Sylfirm X获国家药监局颁发三类医疗器械注册证

Sylfirm X, a dual-wave radiofrequency therapy device exclusively represented by Sihuan Pharmaceutical (00460.HK), was issued a registration certificate for three types of medical devices by the State Drug Administration

Gelonghui Finance ·  Mar 25 00:03

GLONGHUI March 25 丨 Sihuan Pharmaceutical (00460.HK) announced that it is the exclusive agent of the Group and is managed by Korea's Vio Co., Ltd. (Viol.co. , Ltd.) The dual-wave radiofrequency therapy device Sylfirm X (the “Product”) manufactured by (“Vio Korea”) officially obtained a Class III medical device registration certificate issued by China's State Drug Administration on March 19, 2024.

Sylfirm X is the world's first dual-wave radiofrequency treatment device approved by the US Food and Drug Administration (FDA) and the National Drug Administration. It emits high-frequency electric current to promote skin tissue coagulation, which can effectively reduce skin wrinkles and treat atrophic acne scars.

The product uses PW (pulse wave) and CW (continuous wave) dual-wave radio frequency pulse types, eight PW1, PW4/CW1, CW2, CW3, and CW4 dual-wave treatment modes, and uses bipolar uninsulated microneedle electrodes, which can cover the entire layer of skin and dermal treatment, with uniform energy output, and remarkable treatment effects. It targets accurate subcutaneous 0.3 mm-4 mm treatment. The clinical results showed that there were no serious adverse effects related to treatment, and the recovery period after surgery was short. Through precise treatment of 300 μm0.3 s, it is comfortable, painless and without bleeding.

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