K253400

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

510(k) 号: K253400
器械名称: LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
申请人: Shenzhen Saidi Light Therapy Technology Co., Ltd. CN
产品代码: OHS — Light Based Over The Counter Wrinkle Reduction
批准日期: 2025-12-24
受理日期: 2025-09-30
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： K253400.pdf

FDA 官方记录： K253400

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。