K240618

Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens

510(k) 号: K240618
器械名称: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
申请人: Acuity Polymers, Inc. NY · US
产品代码: HQD — Lens, Contact (Other Material) - Daily
批准日期: 2024-04-03
受理日期: 2024-03-05
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Ophthalmic

PDF下载 510(k) Summary本站存档 · 2.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K240618.pdf

FDA 官方记录： K240618

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。