PZK
- 产品代码
- PZK
- 器械名称
- Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
- 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
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
FDA 官方分类页： PZK
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。