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FDA 510(k)

Acuity 18 (enflufocon A) 硬性氣體透過性隐形眼镜，Acuity 58 (enflufocon B) 硬性氣體透過性隐形眼镜，Acuity 85 (Oprifocon A) 硬性氣體透過性隐形眼镜，Acuity 100 (hexafocon A) 硬性氣體透過性隐形眼镜

K 號：K180988 · 2018-06-08

申請人Acuity Polymers, Inc.
決定日期2018-06-08
產品代碼HQD
諮詢委員會此為醫療器材法規文本之翻譯。根據醫療法規翻譯政策，以下為繁體中文譯文： 本文件概述適用於醫療器材之監管架構，包括美國食品藥物管理局（FDA）之上市前審查程序。第510(k)條途徑適用於與已合法上市器材（predicate device）實質等效之器材，而上市前核准（PMA）則為最高風險等級（Class III）器材所要求。臨床證據可能引用NCT編號之試驗登記，或PMID編號之同行評審文獻。所有產品名稱、公司名稱、識別碼及統一資源定位符（URL）均保留原文，以確保可追溯性及法規提交之完整性。
決定相當於

器材摘要

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180988. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K180988.

When did Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180988.

Who is the listed applicant for Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA 510(k) record lists Acuity Polymers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens is HQD.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Acuity Polymers, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242393Acuity 181™ (tisilfocon A) 和 Acuity 181™ (tisilfocon A) 配 Tangible™ Hydra-PEG® 硬性透气隐形眼镜K240618Acuity 200™ (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ (hexafocon A) 硬性透气隐形眼镜; Acuity 200™ 配 Tangible® Hydra-PEG® (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ 配 Tangible® Hydra-PEG® (hexafocon A) 硬性透气隐形眼镜K230965Acuity 100™ (hexafocon A) 配 Tangible™ Hydra-PEG®，TYRO™-97 (hofocon A) 配 Tangible™ Hydra-PEG® 硬性氣體透過性隐形眼镜K213538Acuity 200 配 Tangible Hydra-PEG (fluoroxyfocon A) 硬性透气隐形眼镜K203571Acuity 200 (fluoroxyfocon A) 硬性透气隐形眼镜K201194Acuity 200™ (fluoroxyfocon A) 硬性透气隐形眼镜

查看所有 11 項裝置 →

相關器械（代碼：HQD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253822GPA（六氟酮A）硬式透气性隐形眼镜Zhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) 和 Acuity 181™ (tisilfocon A) 配 Tangible™ Hydra-PEG® 硬性透气隐形眼镜Acuity Polymers, Inc.K241398SDJMASTERVISION（氟氧非酮A）硬式透氧性隐形眼镜Tianjin Mastervision Technology Co., Ltd.K241571波士頓視界® 專業鏡片Boston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ (hexafocon A) 硬性透气隐形眼镜; Acuity 200™ 配 Tangible® Hydra-PEG® (fluoroxyfocon A) 硬性透气隐形眼镜; Acuity 100™ 配 Tangible® Hydra-PEG® (hexafocon A) 硬性透气隐形眼镜Acuity Polymers, Inc.K233325遠見光學角結膜隱形眼鏡（roflufocon D、roflufocon E、hexafocon A、hexafocon B、tisilfocon A、fluoroxyfocon A）Visionary Optics, LLC

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