QIU
- 产品代码
- QIU
- 器械名称
- Intense Pulsed Light Device For Managing Dry Eye
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 886.5201
- FDA 专业组
- Ophthalmic
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
FDA 官方分类页： QIU
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。