K242413
- 510(k) 号
- K242413
- 器械名称
- VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
- 申请人
- Vizionfocus, Inc. TW
- 产品代码
- LPL — Lenses, Soft Contact, Daily Wear
- 批准日期
- 2024-12-17
- 受理日期
- 2024-08-14
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Ophthalmic
FDA 官方记录: K242413
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。