K244009
- 510(k) 号
- K244009
- 器械名称
- Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
- 申请人
- Yung Sheng Optical Co., Ltd. TW
- 产品代码
- LPL — Lenses, Soft Contact, Daily Wear
- 批准日期
- 2025-09-25
- 受理日期
- 2024-12-26
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Ophthalmic
FDA 官方记录: K244009
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。