K250830

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

510(k) 号: K250830
器械名称: LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
申请人: Shenzhen Sungrow Led Technology Co., Ltd. CN
产品代码: OHS — Light Based Over The Counter Wrinkle Reduction
批准日期: 2025-06-09
受理日期: 2025-03-19
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

也可从 FDA 官方下载： K250830.pdf

FDA 官方记录： K250830

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。