K250942
- 510(k) 号
- K250942
- 器械名称
- Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
- 申请人
- Shenzhen Ulike Smart Electronics Co., Ltd. CN
- 产品代码
- OHT — Light Based Over-The-Counter Hair Removal
- 批准日期
- 2025-07-11
- 受理日期
- 2025-03-28
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General, Plastic Surgery
FDA 官方记录: K250942
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。