K252063

Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)

510(k) 号: K252063
器械名称: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
申请人: Wuhan Dimed Laser Technology Co., Ltd. CN
产品代码: GEX — Powered Laser Surgical Instrument
批准日期: 2025-09-25
受理日期: 2025-07-01
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 · 0.8 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252063.pdf

FDA 官方记录： K252063

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。