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FDA 510(k)

保仕康+隆（kalifilcon A）軟性（親水性）隱形眼鏡，保仕康+隆（kalifilcon A）軟性（親水性）隱形眼鏡用於散光，以及，保仕康+隆（kalifilcon A）軟性（親水性）隱形眼鏡用於老花眼

K 號：K220613 · 2023-03-08

申請人Bausch & Lomb, Incorporated
決定日期2023-03-08
產品代碼LPL
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

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K220613. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K220613.

When did Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia receive FDA 510(k) clearance?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia received FDA 510(k) clearance on 2023-03-08, under 510(k) number K220613.

Who is the listed applicant for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

The FDA product code for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is LPL.

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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其他以 Bausch & Lomb, Incorporated 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。

K252052Stellaris Elite™ 视覺增強系統（BL11145、BL14455、BL15455、SE14565、SE15565、SE14565E、SE15565E）K242389EyeGility™ 預裝enVista IOLs植入器K240169Stellaris Elite視覺增強系統（BL11145、BL14455、BL15455）K222541Bausch + Lomb無防腐劑潤滑和重新潤濕眼藥水K202932ABT12 多功能溶液K210975保仕亮（kalifilcon A）軟性（親水性）老花眼隐形眼鏡

查看所有 17 項裝置 →

相關器械（代碼：LPL）

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。

K262495美如1日上昇（米法立酮A）Menicon Co, Ltd.K260507Interojo 45（inofilcon A）柔軟（親水）矽膠水凝片鏡，搭配GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) 每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 彩色每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Polymacon) 彩色柔軟（親水）隱形眼鏡Pegavision CorporationK261299Pegavision (Toufilcon B) 每日抛弃式柔軟（親水）隱形眼鏡；Pegavision (Toufilcon B) 柔軟（親水）隱形眼鏡Pegavision CorporationK253885PUSCON 水平衡-1日顏色調節 (omafilcon A) 轟軟 (親水) 接觸鏡片；PUSCON 水平衡-1日顏色 (omafilcon A) 轟軟 (親水) 接觸鏡片GEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) 可見度著色軟性（親水）隱形眼鏡；Saview SH Optic 38 UV 球面（Senofilcon A）可見度著色軟性（親水）隱形眼鏡；Saview SH Optic 38 UV 多焦距（Senofilcon A）可見度著色軟性（親水）隱形眼鏡St. shine Optical Co., Ltd.

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