K253352

Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

510(k) 号: K253352
器械名称: Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses
申请人: Pegavision Corporation TW
产品代码: LPL — Lenses, Soft Contact, Daily Wear
批准日期: 2026-05-21
受理日期: 2025-09-30
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： K253352.pdf

FDA 官方记录： K253352

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。