NIC
- 产品代码
- NIC
- 器械名称
- Lens, Contact, For Reading Discomfort
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 886.5925
- FDA 专业组
- Ophthalmic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 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
This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
FDA 官方分类页: NIC
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。