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Sofwave Receives FDA, Pre-market Clearance for Pure Impact VIPTM Standalone EMS Device For Comprehensive Multi-Body Area Muscle Strengthening and Firming
Globenewswire· 2025-09-04 12:30
核心观点 - Sofwave Medical Ltd获得FDA 510(k)上市前通知许可 推出独立EMS设备Pure Impact VIP™ 扩展Pure Impact™产品线 [1] 产品与技术 - Pure Impact VIP™作为独立系统 可通过简单直观的程序由员工操作 优化诊所工作流程并提升治疗灵活性 [1][2] - 设备采用基于平板电脑的触控技术及6通道配置 可同时治疗多达6个肌肉群 在外形设计上紧凑直观且性能驱动 [2] - 该平台整合专有的增强式肌肉激活技术 可独立使用或与SUPERB超声系统配合使用 满足身体轮廓塑形需求 [3] 市场与行业 - 麦肯锡报告显示63%的GLP-1患者受访者首次寻求医美服务时选择医疗水疗治疗 [3][5] - 大多数患者将皮肤松弛作为寻求医美服务的主要关注点 [3][5] - GLP-1相关肌肉流失患者对身体轮廓塑形需求增加 推动医美服务需求增长 [3] 公司业务 - Sofwave Medical专注于能量型非侵入性医美设备领域 采用SUPERB™同步超声平行束技术改善面部线条和皮肤松弛 [4] - Pure Impact™模块使用EMS技术 获准用于肌肉塑形 为医生提供智能简单有效且安全的医美解决方案 [4] - 新产品线扩展涵盖腹部、手臂、大腿和臀部等多个身体区域 提供全面的肌肉强化方案 [5]
Sofwave’s liftHD Body Contouring Applicator to Debut at the 44th Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS) 2025
Globenewswire· 2025-04-24 12:30
Four abstract poster presentations highlighting clinical applications and results of Sofwave's SUPERB™ non- invasive medical aesthetic technology will also be on exhibit Launch of the liftHD body applicator provides opportunity for next generation non-invasive aesthetic body treatments which improve cellulite and skin laxity appearance in order to achieve SUPERB results beyond the face Precise depth control – The thermal treatment zone is precisely placed between 0.5mm and 1.8 mm to stimulate natural healin ...