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FDA 510(k)

NewVision SC（tisilfocon A）角結膜塑形鏡片；NewVision SC每日佩戴正畸鏡片（tisilfocon A）角結膜塑形鏡片

K 號：K230910 · 2023-06-16

申請人Acculens, Inc.
決定日期2023-06-16
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

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acculens, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230910. 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 NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Acculens, Inc.. The 510(k) number is K230910.

When did NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens receive FDA 510(k) clearance?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230910.

Who is the listed applicant for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

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

What is the FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

The FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral 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。

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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 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

官方來源

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