K250308
- 510(k) 号
- K250308
- 器械名称
- Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
- 申请人
- Dongguan Boyuan Intelligent Technology Co.,Ltd CN
- 产品代码
- OAP — Laser, Comb, Hair
- 批准日期
- 2025-04-29
- 受理日期
- 2025-02-03
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Physical Medicine
FDA 官方记录: K250308
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。