K244009

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)

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
PDF下载 510(k) Summary本站存档 · 0.4 MB · FDA 公有领域文件

也可从 FDA 官方下载: K244009.pdf

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。