K243465

Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)

510(k) 号: K243465
器械名称: Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
申请人: Guangzhou Chuang Zao Mei Technology Co., Ltd. CN
产品代码: GEX — Powered Laser Surgical Instrument
批准日期: 2025-02-06
受理日期: 2024-11-08
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

PDF下载 510(k) Summary本站存档 · 2.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243465.pdf

FDA 官方记录： K243465

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。