QUR
- 产品代码
- QUR
- 器械名称
- Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 886.5845
- FDA 专业组
- Ophthalmic
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
- 其中 Summary 已存档
- 0 份,可直接下载
- 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
Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| DEN250016 | 2025-09-25 | Essilor Of America, Inc. | Essilor® Stellest® | — |
FDA 官方分类页: QUR
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。