黄金微针
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国产首个黄金微针三类证出炉!半岛医疗破局医美器械赛道
Guo Ji Jin Rong Bao· 2025-10-30 15:14
Core Viewpoint - Peninsula Medical has announced that its "Peninsula Counterclockwise" radiofrequency skin treatment device has received the Class III medical device registration certificate, marking it as the first domestically produced golden microneedle device to obtain this qualification [1] Group 1: Product Development and Certification - The "Peninsula Counterclockwise" device is the first golden microneedle device in China to complete clinical validation and obtain the Class III medical device registration [1] - The device is designed for use in medical institutions to treat atrophic acne scars through the thermal effects of radiofrequency energy on skin tissue [1] - The National Medical Products Administration (NMPA) has set regulations requiring golden microneedles to upgrade to Class III certification by April 1, 2026, and Peninsula Medical has proactively prepared for this transition [1] Group 2: Technological Innovation - The "Peninsula Counterclockwise" features a globally innovative dual-mixed multi-mode output technology, integrating monopolar, bipolar, and combined modes, along with dynamic layering technology to enhance treatment efficacy [1] - The device claims to provide the effect of "one treatment equals five" and includes a negative pressure system and disorderly emission technology to reduce patient discomfort during treatment [1] Group 3: Market Expansion - The product has received dual certification from NMPA and FDA, allowing it to enter international markets, including the Weill Cornell Medical Center in the United States, making it the first domestically produced golden microneedle device to go abroad [1]