K241998
- 510(k) 号
- K241998
- 器械名称
- Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
- 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
- 2024-12-13
- 受理日期
- 2024-07-09
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General, Plastic Surgery
FDA 官方记录: K241998
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。