K230490

PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

510(k) 号: K230490
器械名称: PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
申请人: Dongguan Hunter Electronic Technology Co., Ltd. CN
产品代码: OLP — Over-The-Counter Powered Light Based Laser For Acne
批准日期: 2023-10-27
受理日期: 2023-02-23
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

510(k) Summary（FDA 官方 PDF）： K230490.pdf

FDA 官方记录： K230490

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。