NIZ
- 产品代码
- NIZ
- 器械名称
- Lens, Iris Reconstruction
- 管理类别
- 第 3 类（Class III）
- 21 CFR 条款
- 21 CFR 886.3600
- FDA 专业组
- Ophthalmic
- 上市路径
- 需 PMA 上市前批准
- 标记
- 属植入器械
FDA 分类定义
An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia.
FDA 官方分类页： NIZ
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。