FDA 510(k)

OPTIMUM GP (roflufocon D, roflurocon E) 每日佩戴隐形眼镜，HEXA100 (hexafocon A) 每日佩戴隐形眼镜

K 號：K180616 · 2018-04-25

決定日期2018-04-25

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

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2018-04-25 under 510(k) number K180616. 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 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens?

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is Contamac, Ltd.. The 510(k) number is K180616.

When did OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens receive FDA 510(k) clearance?

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens received FDA 510(k) clearance on 2018-04-25, under 510(k) number K180616.

Who is the listed applicant for OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens?

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

What is the FDA product code for OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens?

The FDA product code for OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens is HQD.

其他以 Contamac, Ltd. 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。

K212631Optimum Infinite (tisilfocon A) 每日佩戴隐形眼镜 K182304超級GP（提西洛康A）每日佩戴隐形眼镜 K181566Nutrifill K171575ENFLU 18（enflufocon A）每日佩戴隐形眼镜 K171077HEXA100（六氟酮A）每日佩戴隐形眼镜 K161100Optimum GP 配合 HPT (roflufocon A, B, C, D 及 E) 每日佩戴隐形眼镜

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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 Bostonsight 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

官方來源

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